Quality Assurance Specialist/Engineer

Senior Scientist - Analytical R&D

General Manager

Senior Specialist - LIMS Administration

Scientist I - Formulations

Quality Assurance Supervisor

Business Unit Leader

Executive Chef of Operations

Job Role: <ul><li>The Biomaterials Business Unit develops, produces and sells monomers and degradable polymers as raw materials for the medical and pharmaceutical industry.&nbsp;</li><li>Our products are used, among other things, in the production of medical devices and controlled release medicines.&nbsp;</li><li>The products are developed and produced to customer specifications in our factories in Gorinchem, The Netherlands and Tucker, GA, USA.&nbsp;</li><li>This requires very intensive contact with the customer. The application area and the specific market require a very high level of quality and service.</li><li>The Biomaterials Quality Assurance department ensures that raw materials, production process, packaging, storage, transport and service continuously meet and exceed these high standards.&nbsp;</li><li>This makes sure that our customers receive the consistent high quality product from our client that they have become accustomed to.</li></ul> Responsibilities: The Quality Engineer is responsible for ensuring procedures, systems and processes effectively meet the Quality and Regulatory requirements and Biomaterials business needs.&nbsp;The successful candidate will be a seasoned professional with experience in pharma, medical device or related FDA regulated industry.&nbsp;The individual should have a thorough working knowledge of ISO 9001; ICH Q7; CFR 210/211; CFR 820; ISO 13485 and other applicable regulations.&nbsp;As Quality Engineer you will be the quality lead in Strategic projects involving introduction of new production processes and/or introduction of new products. <ul><li>Support in maintaining and continuously improving the Quality Management System in compliance with GMP regulations and ISO requirements.</li><li>Provide compliance and quality guidance and training to the Operations, Research and Development and Quality Control departments.</li><li>Interact with internal stakeholders and internal/external customers to ensure Quality and Regulatory requirements for Strategic projects are identified and addressed as part of the project plan.</li><li>Drive the establishment of a proper quality control strategy for new processes and new products by applying quality risk management principles throughout the different phases of Strategic projects.</li><li>Coordinate Quality and Regulatory Affairs relating to Drug Master Files (DMF) and Device Master Files (MAF) ensuring filings meet requirements of Regulatory Agencies and business needs.&nbsp;</li><li>Support Commissioning, Qualification and Validation activities including associated documentation for new equipment.</li><li>Improve quality risk management procedures to ensure periodic review and performance reporting.</li><li>Maintain current knowledge of FDA, EMA and other international regulations, guidelines, and standards (such as ICH, USP, Ph. Eur.) applicable to industry. Monitor and identify developments to the legislations and translate these to the Biomaterials business.</li><li>Perform annual product reviews for commercial products.</li><li>Support the QA department with Audits, CAPA’s, Change Control, Deviations, Root-Cause Analysis, Non-Conformance and Complaint handling.</li></ul>&nbsp;Requirements: <ul><li>Bachelor’s or Masters degree in Chemistry, Engineering, Life Sciences or other relevant area.</li><li>Minimum 2 years of experience as a Quality Engineer in pharmaceutical, medical device or other related industries.</li><li>Experience in maintaining Regulatory filings current and responding to requests from Regulatory Authorities.</li><li>Experience with Commissioning, Qualification and Validation activities for new production equipment.</li><li>Experience in applying Quality Risk Management principles and tools (ICH Q9, HACCP, FMEA, HAZOP, etc.).</li><li>Working knowledge of ISO 9001, ICH Q7, FDA CFR 210/211, CFR 820, ISO 13485 and other applicable regulations.</li><li>Strong written and verbal communication skills, in English and preferably in Dutch.</li><li>Some exposure to customer audits and/or regulatory agency inspections (e.g. FDA, notified bodies, etc.).</li><li>Proven ability to work cross-functionally to achieve business outcomes.</li><li>Attention to detail, commitment to quality, accuracy, efficiency, and consistency.</li><li>Ability to travel occasionally as determined by business requirements.</li></ul>

Responsibilities: <ul><li>Independently lead analytical method develop and validation activities for assigned ANDA products.</li><li>Develop and validate analytical methods for release and stability testing.</li><li>Review and evaluate drug substance supplier’s technical documents and provide recommendation in API vendor selection.</li><li>Identify specification requirements and set up specifications and specification justifications for raw materials and drug products.</li><li>Resolve complex problems in method or product development.</li><li>Develop and understand product stability to guide design of stability studies in support of product registration.</li><li>Generate technical documents to support regulatory submissions.</li><li>Provide timely analytical support on deficiency responses and product approval inspections.</li><li>Review laboratory notebooks, raw data and technical documentation in support of regulatory filings.</li><li>Interact with other depts: Formulations, Regulatory Affairs, Production, Strategic Sourcing, etc., to support timely new product development/submission of new ANDAs.</li></ul> Requirements: <ul><li>Peer review of lab notebooks.</li><li>Evaluate, troubleshoot/improve existing analytical methods when necessary.</li><li>Continuously update knowledge of latest technologies related to analytical science</li><li>Work in compliance with cGMP/cGLP regulations.</li><li>Strong knowledge of analytical chemistry and concepts in developing and validating methods to meet correct pharmaceutical standards.</li><li>Superior knowledge of major analytical techniques such as HPLC/UPLC, dissolution, FT-IR, physical characterization, etc.</li><li>Strong knowledge of FDA, ICH, and USP guidance and regulations.</li></ul>

Job Description: <ul><li>Manages and directs the operation of multiple airline catering units or “flight kitchens” with individual gross revenues of $350,000 to $7M+ and direct and indirect headcount of 10 to 100+ employees.</li></ul> Responsibilities: <ul><li>Leads and manages exempt staff of all Departments in the Airline Catering unit.</li><li>This includes but not limited to: Food production, Transportation, Equipment Processing, Storeroom Department, Dish-room/Porters, Quality Assurance, and related departments to ensure production standards and customer service requirements are met.</li><li>Ensures Customer requirements/specifications and service requirements are complied with on all airline accounts. This includes production processing, on-time performance, equipment inventory, and quality assurance controls.</li><li>Drives to meet business objectives and goals set by superior related to food costs, labor costs, sanitation, quality assurance, market track goals, airline goals and objectives, and all other specific goals set thereof.</li><li>Ensures that all HACCP, FDA, Local Airport, Quality Assurance, and Airline Specifications are maintained at the highest level.</li><li>Monitors all menu cycles to ensure customer service and satisfaction is not interrupted. Ensures that proper equipment is maintained and controlled in the Unit for operation excellence.</li><li>Manages operation staff on a day-to-day operation aspect to drive for exceeding set targets.</li><li>Supports and assist Lean initiatives, and Quality initiatives to achieve OPEX targets.</li><li>Monitors all training programs that are required to be conducted to ensure all Corporate Polices and Procedures are followed and maintained.</li><li>Monitors employee relations in each Department, and ensures compliance with the National Master and Local Addendum labor agreements are maintained in the Departments.</li><li>Supports customer audits, government audits to meet compliance</li><li>Responsible for annual performance evaluations of direct reports in compliance with corporate initiatives.</li><li>Maintains customer communication with all local and corporate airline representatives to ensure all request, investigations, and/or related are concluded to the satisfaction of the customer and company.</li><li>Assists the Regional GM on projects, investigations, training, corporate goals and objectives, and airline requests.</li><li>Completes all administrative reports in an accurate and timely manner.</li><li>Ensures the security of the facility by monitoring and maintaining existing programs including all TSA, local airport and corporate requirements.</li><li>Drives prevention vs. detection of defects.</li><li>Coordinates actions to prevent the occurrences of nonconformities.</li><li>Maintains customer compliance resolution.</li><li>Responsible for the maintenance of key performance metrics for the Operation organization.</li><li>Verifies and insures company policies and procedures are followed.</li><li>Insures quality specifications and requirements are followed and met.</li><li>Develop Standard Operating Procedures.</li><li>Responsible for safety, quality and compliance to customer specification.</li><li>Completes Hazard Analysis and Risk Based Preventative Controls (HARPC) Preventative Controls for Human Food training and certification course to be a PCQI (Preventive Controls Qualified Individual) according to company policy.</li><li>Completes all company required training including but not limited to ServSafe Sanitation Manager Certification.</li></ul>&nbsp;Requirements: Education: <ul><li>Associate or Bachelor’s degree in business administration or a related field is preferred</li></ul>&nbsp;Work Experience: <ul><li>Successful track record as a Manager or Assistant Manager in airline catering required. 10+ years of experience in in-flight catering or food manufacturing environment required.&nbsp;</li><li>Demonstrated experience with managing financials with budget responsibility for a single operating unit required, multiple operating units preferred.&nbsp;</li><li>Demonstrated knowledge of Lean manufacturing principles and/or six sigma and continuous improvement methodologies preferred.</li><li>&nbsp;Proven experience successfully managing a team of supervisors and managers for a single operating unit required, multiple operating units preferred.&nbsp;</li><li>Previous customer service and/or account management experience required.&nbsp;</li><li>Strong track record of innovation and making changes to the operation to further improve the work environment and unit performance Labor relations experience is required.</li></ul> Technical Skills: (Certification, Licenses and Registration): <ul><li>Candidate should be comfortable with all levels of employees and have the ability to drive positive program change.&nbsp;</li><li>Must be a Team builder with the ability to lead and motivate a diverse management and hourly staff.&nbsp;</li><li>Must have strong and effective leadership skills Excellent problem solving skills, planning and scheduling capabilities managing multiple account requirements Ability to effectively manage multiple operations while maintaining compliance in a heavy regulated environment e.g.&nbsp;</li><li>FDA, HACCP and security.&nbsp;</li><li>Advanced Microsoft office tool skills (excel, word). Knowledge of quality auditing, inspection methods.</li><li>&nbsp;Detail oriented and excellent project management skills.&nbsp;</li><li>Strong organizational skills, able to prioritize responsibilities and multi-task. Change Agent. Able to obtain an AOA badge and customs seal</li></ul> Language / Communication Skills: <ul><li>Strong interpersonal skills and the ability to interact effectively with multiple departments and customers Excellent written and oral communication skills.</li></ul> Job Dimensions: <ul><li>Geographic Responsibility: Unit/Region</li><li>Type of Employment: Full-time</li><li>Travel %: Up to 25% as required to attend management or leadership meetings</li><li>Exemption Classification: Exempt</li><li>Internal Relationships: Employees at all levels of the organization</li><li>External Relationships: Customers</li></ul> Work Environment / Requirements of the Job: <ul><li>Regularly, stands, bends, lifts, and moves intermittently during shifts of 10+ hours.</li><li>In a normal production kitchen facility there may be physical discomfort due to temperature and noise.&nbsp;</li><li>Must be able to lift, push, pull and move product, equipment, supplies, etc., in excess of twenty-five (25) pounds.&nbsp;</li><li>A rotating schedule of 55+ hours per week is typical.</li><li>Budget / Revenue Responsibility: $350,000 to $7M+</li></ul> Organization Structure: <ul><li>Direct Line Manager (Title): VP, BU</li><li>Number of Direct Reports: 30+</li><li>Estimated Total Size of Team: 30+</li></ul>

Role Description: <ul><li>Reporting to the Hub BU Leader, this position leads and manages the Culinary/Hot Kitchen, Assembly and Transportation departments of the airline catering unit or “flight kitchen” with gross revenues of $100+ million and direct and indirect headcount of 1,000+ employees.</li></ul> Responsibilities: <ul><li>Leads and manages Culinary/Hot Kitchen, Assembly and Transportation departments to ensure production standards and customer service requirements are met.</li><li>Drives to meet business objectives and goals set by superior related to food costs, labor costs, sanitation, quality assurance, market track goals, airline goals and objectives, and all other specific goals set thereof.</li><li>Responsible for the maintenance of key performance metrics for the departments.</li><li>Ensures Customer requirements/specifications and service requirements are complied with on all airline accounts; this includes production processing, on-time performance, equipment inventory, and quality assurance controls.</li><li>Maintains customer communication with all local and corporate airline representatives to ensure all request, investigations, and/or related are concluded to the satisfaction of the customer and company.</li><li>Supports customer audits and government audits to meet compliance.</li><li>Monitors all menu cycles to ensure customer service and satisfaction is not interrupted.</li><li>Ensures that all HACCP, FDA, Local Airport, Quality Assurance, and Airline Specifications are maintained at the highest level.</li><li>Supports and assists Lean initiatives, and Quality initiatives to achieve OPEX targets.</li><li>Ensures that proper equipment is maintained and controlled in the Unit for operation excellence.</li><li>Ensures all Corporate Policies and Procedures are followed and maintained.</li><li>Develops Standard Operating Procedures.</li><li>Ensures the security of the facility by monitoring and maintaining existing programs including all TSA, local airport and corporate requirements.</li><li>Manages operation staff on a day-to-day operation aspect to drive for exceeding set targets.</li><li>Responsible for annual performance evaluations of direct reports in compliance with corporate initiatives.</li><li>Monitors employee relations in each Department, ensures compliance with the National Master and Local Addendum labor agreements in the Departments.</li><li>Assists the BU leader on projects, investigations, training, corporate goals and objectives, and airline requests.</li><li>Completes Hazard Analysis and Risk Based Preventative Controls (HARPC) Preventative Controls for Human Food training and certification course to be a PCQI (Preventive Controls Qualified Individual) according to company policy.</li><li>Completes all company required training including but not limited to ServSafe Sanitation Manager Certification.</li></ul> Requirements: Education: <ul><li>Bachelor’s degree in business administration or related field required</li></ul> Work Experience:&nbsp; <ul><li>Successful track record as a Manager or Assistant Manager in airline catering required.</li><li>Minimum 10 years of management experience in in-flight catering or food manufacturing environment required.</li><li>Proven experience successfully managing a team of supervisors and managers for a single operating unit required</li><li>Demonstrated knowledge of Lean manufacturing principles and/or six sigma and continuous improvement methodologies preferred.</li><li>Previous customer service and/or account management experience required.</li><li>Strong track record of innovation and making changes to the operation to further improve the work environment and unit performance</li><li>Labor relations experience is required</li></ul> Technical Skills: (Certification, Licenses and Registration) <ul><li>Must have strong and effective leadership skills</li><li>Must be comfortable with all levels of employees and have the ability to drive positive program change.</li><li>Must be a Team builder with the ability to lead and motivate a diverse management and hourly staff</li><li>Excellent problem solving skills, planning and scheduling capabilities managing multiple account requirements</li><li>Ability to effectively manage multiple operations while maintaining compliance in a heavy regulated environment e.g. FDA, HACCP and security</li><li>Advanced Microsoft office tool skills (excel, word)</li><li>Knowledge of quality auditing, inspection methods</li><li>Detail oriented and excellent project management skills</li><li>Strong organizational skills, able to prioritize responsibilities and multi-task</li><li>Change Agent</li><li>Able to obtain an AOA badge and customs seal.</li></ul> Language / Communication Skills: <ul><li>Strong interpersonal skills and the ability to interact effectively with multiple departments and customers</li><li>Excellent written and oral communication skills.</li></ul> Job Dimensions Geographic Responsibility: Hub Unit Type of Employment: Full TimeTravel %: Up to 25% as required to attend management or leadership team meetings Exemption Classification: Exempt Work Environment / Requirements of the Job: production kitchen facility (there may be physical discomfort due to temperature and noise) Competencies Required to be Successful in the Job: <ul><li>Thinking – Information Search and analysis &amp; problem resolution skills</li><li>Engaging – Understanding others, Team Leadership and Developing People</li><li>Inspiring – Influencing and building relationships, Motivating and Inspiring, Communicating effectively</li><li>Achieving – Delivering business results under pressure, Championing Performance Improvement and Customer Focus</li></ul> Demonstrated Values to be Successful in the Position <ul><li>Expected to live our Values of Excellence, Integrity, Passion and Accountability. To demonstrate these Values, we expect to observe the following from everyone:</li><li>We treat each other with respect and we act with integrity</li><li>We communicate and keep each other informed</li><li>We put our heads together to problem solve and deliver excellence as a team</li><li>We have passion for our work and we pay attention to the little details</li><li>We foster an environment of accountability, take responsibility for our actions and learn from our mistakes</li><li>We do what we say we will do, when we say we are going to do it</li><li>We care about our coworkers, always taking an opportunity to make someone’s day better</li></ul>

Responsibilities: <ul><li>Prepares crystal reports.</li><li>Creates or approves static data entries.</li><li>Adds/modifies calculations, workflows, and schemas as necessary.</li><li>Codes LIMS system to customize software platform.</li><li>Integrates and customizes software with laboratory instrumentation</li><li>Responsible for instrument integration.</li><li>Builds Crystal Reports.</li><li>Builds/Configure Electronic Laboratory Notebooks.</li><li>Participate in cross-site implementation of new LIMS features and enhancements</li><li>Coordinates roll-out of additional LIMS phases..</li><li>Assists in Project Planning and Budget Spending.</li><li>Performs periodic audits on the system, collates and presents the results of the audit to senior management.</li><li>Develop training modules and provide user training as necessary.</li><li>Interact with laboratory personnel to ensure necessary developments are present and functioning, as necessary.</li><li>Interface with IT department on global LIMS issues.</li><li>Follows EH&amp;S procedures to ensure a safe work environment.</li><li>Performs other LIMS-related responsibilities as required by management.</li></ul> Requirements: <ul><li>Bachelor’s degree in life science, physical science, or technology field with 5+ years’ laboratory experience performing development functions for a GMP laboratory</li><li>3+ years’ experience within software development</li><li>Worked within a regulated environment (Pharmaceuticals, Medical Devices, Biotech or other regulated field)</li></ul> Knowledge: <ul><li>Knowledge of 21 CFR Part 11</li><li>Strong knowledge of Computer System Validation techniques and practices</li><li>Company SOPs applicable to job</li><li>Thorough knowledge of general routine laboratory operations and workflow, with the ability to integrate those processes into an electronic workflow</li><li>Strong understanding of Company SOPs applicable to job</li><li>GMP Knowledge of FDA regulations, primarily GMP regulations</li><li>Thorough knowledge of general routine laboratory operations and workflow, with the ability to integrate those processes into an electronic workflow</li><li>In-depth knowledge of Crystal Reports, SQL programming, and SSL scripts or other varying scripting languages such as JavaScript, SQL, Java</li></ul> Skills &amp; Abilities: <ul><li>Advanced computer skills</li><li>Strong attention to detail. Highly productive, able to manage time and prioritize tasks to meet timelines</li><li>Strong interpersonal and communication skills; confident presenter, clear, concise technical writer.&nbsp;Able to interact with various departments and levels</li><li>Customer focused</li><li>Troubleshooting and critical thinking skills. Able to define problems, collect data, establish facts and draw conclusions</li></ul>

Role Description: <ul><li>The Scientist I, Formulations provides scientific/technical support to enable formulation, product development, scale-up and manufacturing process optimization in support of NDA and ANDA submissions.</li><li>Will also assist with implementation of systems necessary for product development in a regulated environment.</li></ul> Responsibilities: <ul><li>Assists in design of experimental plans; performs pre-formulation, formulation development work on immediate and controlled release dosage forms.</li><li>Assists in design of studies related to pre-formulation and formulation of oral, ocular and inhalation products that may impact the stability and delivery of the product in collaboration with other disciplines.</li><li>Responsible for batch production from pilot scale to process validation and de-formulation activities to support generic dosage forms.</li><li>Assist in the development and evaluation of proposed formulations, processing procedures, including selection of container/closure systems.</li><li>Generates and reviews analytical data to support the product development work.</li><li>Assists with writing of experimental designs to carry out process development and evaluation work, limited scale-up in support of Abbreviated New Drug Applications (ANDAs) and New Drug Applications (NDAs) submission to regulatory agency.</li><li>Plans appropriate analytical testing and stability studies on experimental batches</li><li>Generate documents in support of Regulatory submissions and may author portions of CMC section of submissions.</li><li>Collaborates with Scientists, to develop and track project timelines and assumes departmental responsibilities for projects when necessary.</li><li>Effectively communicates own work, orally and in writing, at team meetings, in technical documents, and to external partners. Participate in cross-departmental project teams as required.</li><li>Performs literature searches, attends scientific meetings, and keeps abreast of literature relevant to oral, ocular, and nasal formulation development.</li></ul> Requirements: <ul><li>Bachelor’s degree in Pharmacy and/or Chemistry with some relevant pharmaceutical industry experience preferred.</li><li>Good knowledge of MS Office Suite required.</li><li>Basic knowledge of FDA regulations preferred.</li><li>Ability to define and solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.</li><li>Analytical- Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data; Designs work flows and procedures.</li><li>Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations; Uses reason even when dealing with emotional topics.</li><li>Technical Skills - Assesses own strengths and weaknesses; Pursues training and development opportunities; Strives to continuously build knowledge and skills; Shares expertise with others.</li><li>Interpersonal Skills - Focuses on solving conflict, not blaming; Maintains confidentiality; Listens to others without interrupting; Keeps emotions under control; Remains open to others ideas and tries new things.</li><li>Ethics - Treats people with respect; Keeps commitments; inspires the trust of others; Works with integrity and ethically; Upholds organizational values.</li><li>Motivation - Sets and achieves challenging goals; Demonstrates persistence and overcomes obstacles; Measures self against standard of excellence; Takes calculated risks to accomplish goals.</li><li>Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently; Plans for additional resources; Sets goals and objectives; Organizes or schedules other people and their tasks; Develops realistic action plans.</li><li>Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.</li><li>Quantity - Meets productivity standards; Completes work in timely manner; Strives to increase productivity; Works quickly.</li><li>Innovation - Displays original thinking and creativity; Meets challenges with resourcefulness; Generates suggestions for improving work; Develops innovative approaches and ideas; Presents ideas and information in a manner that gets attention.</li></ul>

Responsibilities: <ul><li>Manage and schedule quality activities performed by QA Associates (batch record stage review, production quality inspection/ sampling /testing, etc.</li><li>Raw Material/Packaging Component/Bulk Drug Product Release.</li><li>Manage and coordinate raw material sampling/ release and bulk products review/release performed by QA Associates.</li><li>Manage and coordinate equipment swabbing and release performed by QA Associates.</li><li>Oversee liquid retains sample management and APR review.</li><li>Provide expertise to operations to resolve floor issues, implement corrections, and assure deviations are opened.</li><li>Collaborate with various departments to meet quality requirements and fulfill business needs.</li><li>Provides manager with quality indicator data derived from supporting systems such as CME.</li><li>Coordinates interdepartmental activities with QC, Supply Chain and Operations to meet business needs.</li><li>Responsible for quarantining/rejecting product due to investigations disposition, field alerts, recalls, etc.</li><li>Responsible for overseeing movement of controlled substance within their designated facility to and from secured location.</li><li>Back up reviewer and approver of master packaging records in support of operations.</li><li>Back up QA reviewer of environmental monitoring alarms.</li><li>Back up for executed&nbsp;packaging and manufacturing batch record review.</li><li>Author and review SOPs relevant to the job duties.</li><li>Initiate deviation reports and supports investigative process.</li><li>Monitor manufacturing and packaging processes to assure cGMP compliance and adherence to company SOPs.</li><li>Assist internal quality initiatives and internal audits as required; assist as needed with FDA inspections.</li><li>Provides guidance, training, cross-training, coaching and work assignments for QA Associates.</li><li>Selects, develops, evaluates personnel to ensure efficient operation of QA function.</li></ul> Requirements: <ul><li>Bachelor’s degree in Chemistry, Life Science, or related field.</li><li>7+ years of related experience in in a cGMP/pharmaceutical environments or equivalent.</li><li>2+ years’ supervisory experience.</li><li>Experienced in training techniques.</li></ul> Knowledge: <ul><li>Understanding of cGMP&nbsp;principles, solid dosage manufacturing and packaging, DEA regulations</li><li>Solid understanding and use of ANSI sampling techniques and principles.</li><li>Intermediate computer skills.</li></ul> Skills &amp; Abilities: <ul><li>Problem Solving - Identifies and resolves problems in a timely manner; gathers and analyzes information skillfully; develops alternative solutions; works well in group problem solving situations; uses reason even when dealing with emotional topics.</li><li>Technical Skills - Assesses own strengths and weaknesses; pursues training and development opportunities; strives to continuously build knowledge and skills; shares expertise with others.</li><li>Customer Service - Manages difficult or emotional customer situations; responds promptly to customer needs; solicits customer feedback to improve service; responds to requests for service and assistance; meets commitments.</li><li>Interpersonal Skills - Focuses on solving conflict, not blaming; maintains confidentiality; listens to others without interrupting; keeps emotions under control; remains open to others ideas and tries new things.</li><li>Oral Communication - Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; responds well to questions; demonstrates group presentation skills; participates in meetings.</li><li>Written Communication - Writes clearly and informatively; edits work for spelling and grammar; varies writing style to meet needs; presents numerical data effectively; able to read and interpret written information.</li><li>Quality Management - Looks for ways to improve and promote quality; Demonstrates accuracy and thoroughness.</li><li>Able to effectively handle conflict/resolution situations between different departments and inter-department.</li><li>Able to analyze and troubleshoot problems.</li></ul>

Responsibilities: <ul><li>Accountable for all aspects of the business of the unit</li><li>Drives positive relationships with all customers of the unit</li><li>Demonstrates financial acumen by ensuring budgets are created accurately, communicated out, responsibility aligned and budget delivered</li><li>Actively researches and understands the local business arena, local culture and understands where the unit sits within the local framework, adapting where necessary</li><li>Monitors, reviews, guides direct reports to work together as a high performing team</li><li>Continually develops and improves the skills of the employees by working with HR, Learning &amp; Development and by mentoring and coaching the management team</li><li>Takes full ownership to lead compliance adherence of the unit to all regulatory, customer and internal policies and procedures</li><li>Identifies root causes of any situation which occurs and creates a robust action plan to work through to a robust solution</li><li>Justifies proposals/business cases for expenditure to improve the business unit</li><li>Identifies, and leads where appropriate, continuous and process improvement initiatives that drive the unit forward</li><li>Works with the HR Business Partner for salary review processes, ensuring to balance engagement, reward and cost effectiveness and keep competitive advantage</li><li>Constantly monitors recruitment to ensure that the unit have the right people in the right place at the right time</li><li>Puts into practice operational policies and decisions that come from the Executive Management Team, maintaining alignment with company and divisional policy and procedures</li><li>Completes Hazard Analysis and Risk Based Preventative Controls (HARPC) Preventative Controls for Human Food training and certification course to be a PCQI (Preventive Controls Qualified Individual) according to company policy.</li><li>Completes all company required training including but not limited to ServSafe Sanitation Manager Certification.</li></ul> Requirements: Education: <ul><li>Bachelor’s degree in business administration or related field required&nbsp;</li></ul> Work Experience:&nbsp; <ul><li>Successful track record as a General Manager in airline catering required.</li><li>Minimum 15 years of management experience in in-flight catering or food manufacturing environment required.</li><li>Demonstrated experience with managing financials with budget responsibility for a single operating unit required, multiple operating units preferred.</li><li>Demonstrated knowledge of Lean manufacturing principles and/or six sigma and continuous improvement methodologies preferred.</li><li>Proven experience successfully managing a team of supervisors and managers for a single operating unit required, multiple operating units preferred.</li><li>Previous customer service and/or account management experience required.</li><li>Strong track record of innovation and making changes to the operation to further improve the work environment and unit performance</li><li>Labor relations experience is required</li></ul> Technical Skills: (Certification, Licenses and Registration): <ul><li>Must have strong and effective leadership skills</li><li>Must be comfortable with all levels of employees and have the ability to drive positive program change.</li><li>Must be a Team builder with the ability to lead and motivate a diverse management and hourly staff</li><li>Excellent problem-solving skills, planning and scheduling capabilities managing multiple account requirements</li><li>Ability to effectively manage multiple operations while maintaining compliance in a heavy regulated environment e.g. FDA, HACCP and security</li><li>Advanced Microsoft office tool skills (excel, word)</li><li>Knowledge of quality auditing, inspection methods</li><li>Detail oriented and excellent project management skills</li><li>Strong organizational skills, able to prioritize responsibilities and multi-task</li><li>Change Agent</li><li>Able to obtain an AOA badge and customs seal.</li></ul> Language / Communication Skills: <ul><li>Strong interpersonal skills and the ability to interact effectively with multiple departments and customers</li><li>Excellent written and oral communication skills.</li></ul>

Job Summary:Reporting to the General Manager of the unit, the Executive Chef, Operations is responsible for daily monitoring of the preparation of the pre-designed meals for multiple customer accounts with culinary expertise through the management of all Chefs, Sous Chefs and Cooks at the unit, and promoting and providing quality food services to airline clients.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Responsibilities: <ul><li>Achieves culinary operational objectives by contributing information and analysis to strategic plans and reviews; preparing and completing action plans; implementing production, productivity, quality, and customer-service standards; serving as culinary resource to operations managers; identifying and resolving problems; completing audits; determining system improvements; implementing change.&nbsp;</li><li>Meets culinary financial objectives by estimating requirements; assisting with menu design; anticipating and evaluating response to menu presentation; scheduling expenditures; analyzing variances; initiating corrective actions; evaluating time-saving production techniques; training others in specialty techniques.&nbsp;</li><li>Adheres to recipes and portion specifications as required by the customer by understanding consumer tastes and nutritional needs; reviewing product specifications; evaluating ease of menu preparation; applying established procedures and budgetary constraints.&nbsp;</li><li>Oversees food preparation by consulting with the Buyer; Sous chefs, cooks, and team leaders; overseeing portion size; controlling productivity; providing culinary leadership in areas of personal expertise; monitoring presentations, garnishments, and sauces.&nbsp;</li><li>Improves menu quality and consistency by analyzing food production records and menu expenses; promoting kitchen staff interest in quality improvement; studying, evaluating, and re-designing processes; implementing changes.&nbsp;</li><li>Prepares menu and food preparation reports by collecting, analyzing, and summarizing food, dining, and customer data and trends.&nbsp;</li><li>Maintains safe, secure, and healthy work environment by establishing, following, and enforcing standards and procedures; complying with sanitation and federal, state, and local legal regulations; overseeing food preparation, safety, and security; reviewing and implementing accident and disaster plans.&nbsp;</li><li>Using menu specifications, maintains food ingredients, food preparation, and general supplies by selecting and purchasing menu ingredients; evaluating the quality of fresh food and food product deliveries; maintaining general supplies; establishing inventory levels, re-order points, storage requirements, and cost-controls.&nbsp;</li><li>Maintains culinary equipment by following operating instructions; instructing staff in equipment use; troubleshooting breakdowns; maintaining equipment supplies; performing preventive maintenance; calling for repairs; evaluating new equipment; preparing administrative proposals to justify purchases.&nbsp;</li><li>Maintains professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; benchmarking state-of-the-art practices; being sought for opinions as a culinary expert; contributing to professional publications; participating in professional societies and sharing this information with direct reports.&nbsp;</li><li>Accomplishes culinary goals by accepting ownership for accomplishing new and different requests; exploring opportunities to add value to job accomplishments. </li><li>Ensures quality production standards are followed and maintained. Ensures employees adhere to HACCP, FDA and safety regulations and compliance with company policies and procedures. </li><li>Trains and monitors employees on proper work procedures and production of products to ensure maximum productivity with minimum labor and food expenses. </li><li>Assists in the development and training of cooks as required. </li><li>Prepares administrative reports as required. </li><li>Ensures maximum productivity and labor costs are maintained according to financial requirements. Monitors daily manpower planning and employee turnover.&nbsp;Responsible for employee retention.&nbsp;</li><li>Ensures meal cycles are communicated in a timely and accurate basis. Monitor yields of products to ensure maximum usage. </li><li>Works with management staff to improve performance of the unit. </li><li>Ensures Menu presentations are properly planned, set up, and specifications reviewed to ensure compliance. </li><li>Maintains labor requirements, food costs, overtime, and all productivity requirements. </li><li>Must ensure all cooks, and Sous Chef employees have the skill and ability to perform all cooking and food preparation requirements of all the Airline Accounts serviced in the Unit. </li><li>Ensures all products are cooked at required temperature according to airline and food safety specification, etc. </li><li>Responsible for coaching, counseling and preparing corrective action for employees. </li><li>Completes all company required training including but not limited to ServSafe Sanitation Manager Certification.</li></ul> Requirements: Education:<ul><li>Associate Degree or Bachelor Degree in the&nbsp;Culinary Arts or a related field, (formal culinary education) required or at least 4 years of experience in an Executive Chef role</li></ul>&nbsp;Work Experience: <ul><li>Minimum&nbsp;10&nbsp;years of experience as a&nbsp;Chef required </li><li>Minimum of 4 years of experience as an Executive Chef&nbsp;required. </li><li>Minimum of&nbsp;1-3 years of supervisory&nbsp;experience working in a high volume, manufacturing, food production and restaurant or catering environment&nbsp;required. </li><li>In-flight catering experience or experience in a high-volume food service environment required. </li></ul>&nbsp;Technical Skills: (Certification, Licenses and Registration)<ul><li>Ability to cook meals according to detailed specifications. </li><li>Ability to work in a fast paced, deadline driven environment. </li><li>Must have strong and effective leadership skills, and the ability to successfully manage a staff of 2 to 3 Sous Chefs and over 20 cooks. </li><li>Current or previous labor relations experience is a plus, but not required. </li><li>Candidate must be comfortable with all levels of employees and have the ability to drive positive program change. </li><li>Ability to train others required. </li><li>Must have the ability to give negative and positive feedback to employees on a daily basis. </li><li>Excellent time management skills required.&nbsp;Ability to handle multiple tasks without losing focus on priorities. </li><li>Strong organizational, analytical, communication and leadership skills required. </li><li>Must be innovative and have the ability to make changes to the operation as needed to further improve the work environment and unit performance. </li><li>Experience with menu design a plus</li><li>Basic computer skills required.&nbsp;Working knowledge of Microsoft Office products preferred</li></ul>&nbsp;Technical Skills: (Certificates, Licenses and Registration)<ul><li>ServSafe Certified preferred. </li></ul>&nbsp;Language / Communication Skills:<ul><li>Must have excellent written and oral communication skills.&nbsp;</li><li>Multi-lingual&nbsp;a plus.</li></ul>

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Quality Assurance Specialist/Engineer

Senior Scientist - Analytical R&D

General Manager

General Manager

Senior Specialist - LIMS Administration

Scientist I - Formulations

Quality Assurance Supervisor

Business Unit Leader

Executive Chef of Operations

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Skills

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9 fda Jobs found

Quality Assurance Specialist/Engineer

Senior Scientist - Analytical R&D

General Manager

General Manager

Senior Specialist - LIMS Administration

Scientist I - Formulations

Quality Assurance Supervisor

Business Unit Leader

Executive Chef of Operations

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WhiteCrow is on a mission to connect companies with the best talent across the globe.