Mgr II Qlty & Reliability Engineering

Head of Commercial Operations

Warehouse Supervisor/Manager

Operations Supervisor

Quality Control Supervisor

Analytical Quality Assurance Specialist

Electrical/Controls Technician

Lead Quality Specialist - Investigator

Halal Executive Chef

QC Chemist I

Responsibilities: <ul><li>Manages plant quality staff across quality systems and product quality.</li><li>Oversees the quality and documentation system and quality records program.</li><li>Manages QMS processes for management review, CAPA, regulatory agencies, customer and internal audits.</li><li>Manages and provides resources for new product development, quality engineering, inspection, measurement,and test, complaint handling, non-conforming product and MRB resolution.</li><li>Ensures compliance to FDA QSR, ISO, MDD and other applicable requirements.</li><li>Site Management Representative for the TEM quality system.</li><li>Ensure product safety, reliability and quality through the effective use of quality planning, risk analysis,statistical methods and process controls.</li><li>Provides sales and marketing support in explaining quality system and regulatory compliance capability tocustomers.</li><li>Contributes with the strategic Site team effort to accomplish results as needed</li><li>Provides leadership in the continuing evolution, improvement, and efficiency of the quality function.</li><li>Develops quality personnel to assure continuity and personal growth.</li><li>Understands and complies with all company rules and regulations.</li><li>Builds a Safe and Inclusive environment</li></ul> Requirements: Qualification &amp; Experience: <ul><li>10 years or more in a quality function with 5 years or more in management position.</li><li>BS/BA degree with a scientific/engineering emphasis required.</li><li>Leadership skills</li><li>Technical discipline or quality professional training.</li><li>Statistical techniques, metrology, and process analysis training.</li><li>Quality system design and implementation experience.</li><li>Lead and supportive on external audits.</li><li>Risk management .</li><li>Regulatory requirements and reporting responsibilities.</li><li>Supply chain development and management.</li><li>Strong analytical skills and attention to detail.</li><li>Excellent interpersonal and written communication skills.</li><li>Demonstrated ability to effectively organize, prioritize and accomplish multiple tasks, make decision and solveproblems independently.</li><li>A thorough knowledge of 21 CFR and ISO 13485.</li><li>Commitment to ethical conduct and responsibility.</li><li>Experience with MS Word, Excel, Project Management and Analytics software</li></ul>

Reponsibilities: Product Level Strategy <ul><li>Market data and internal financials</li><li>Strategy (gain share, hold share, rationalize volume, improve price, etc.)</li><li>Target share</li><li>Inventory targets based on market dynamics, product strategy, etc.</li><li>Provides input for Product Champions</li><li>Decision-making for Day-to-day Commercial Operations</li><li>Incorporate Product Strategies while leading/making the following decisions:</li><li>Order processing</li><li>ROFR responses</li><li>New business bids</li></ul> Rolling 12-month forecasts <ul><li>New Product Intel and Near-term Launch Evaluation &amp; Tracking</li><li>Maintain master database of future product pipeline information at the customer level.</li><li>Share with Portfolio as needed.</li><li>Assess the right frequency of pricing &amp; volume intel requirements</li><li>Interpret the accuracy of intel based on existing data points and those gathered via subscriber information (IQVIA, export data, etc.)</li><li>Rolling 12-month New Product Launch Prioritization and Planning</li></ul> Tracking results vs. business case on new launches <ul><li>Provide leadership for Product Management, Pricing/Contracts, Customer Service, Forecasting and Marketing</li><li>Identify/execute process improvements, including IT solutions</li><li>Manage all aspects of OTB strategies &amp; tactics (price, vol, production)</li><li>Improve UPS execution and shipping costs while analyzing other 3PLs</li></ul> Requirements: Qualifications Education &amp; Experience <ul><li>Minimal acceptable level of education, work experience and certifications required for the job</li><li>Bachelor’s or master’s degree preferred</li><li>10 plus years related work experience in the pharmaceutical industry, preferably generics</li><li>Excellent computer skills, including data collection experience</li></ul> Knowledge&nbsp; <ul><li>Proficiency in a body of information required for the job e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.</li><li>Industry/Customer recognition</li><li>Financial acumen</li></ul> Skills &amp; Abilities <ul><li>Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific (e.g. coaching, negotiation, calibration, technical writing etc.)</li><li>Interpersonal Skills - Focuses on solving conflict; Maintains confidentiality; works well in a collaborative environment</li><li>Adapts to changes; Manages competing demands; Changes approach or method to best fit the situation; Able to deal with frequent changes or unexpected events. Teamwork - Balances team and individual responsibilities; Exhibits objectivity and openness to others views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Able to build morale and group commitments to goals and objectives; Supports everyones efforts to succeed.</li><li>Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data; Designs workflows 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>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></ul> Physical Requirements <ul><li>Physical &amp; mental requirements (e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.)</li><li>General Office environment</li><li>Occasional Travel</li></ul>

Responsibilities: Distribution Operations <ul><li>Oversee all distribution operations for the warehouse, assuring timely accurate and cost-effective deliveries.</li><li>Direct cycle counting procedures to maintain accurate inventory.</li><li>Review all transportation billing for accuracy before sending to AP.</li><li>Execute contract customer shipments to ensure timely deliveries.</li><li>Maintain and administers all departmental policies, SOP’s and training.</li></ul> Compliance and Audit <ul><li>Ensure compliance with all safety and regulatory guidelines.</li><li>Maintain the warehouse, shipping/receiving areas and distribution center in audit ready condition including upholding a strict level of cleanliness.</li><li>Ensure that all documentation is up to date and easily accessible.</li><li>Maintain an on-going relationship with Supply Chain for inventory and shipments issues.</li><li>Must be current with all federal counterfeit drug regulations, E-pedigree state laws and ASN rules and regulations with the wholesalers.</li></ul> Cross-Functional Support <ul><li>Maintain training records for all colleagues in your organization and ensure 100% compliance to training guidelines.</li><li>Work with finance on a monthly basis to ensure all shipments and customer orders have been processed are resolved for months end.</li><li>Works closely with Quality and Regulatory on all related issues. anticipates in audits as needed.</li></ul> Requirements: Education &amp; Experience	 <ul><li>Minimal acceptable level of education, work experience and certifications required for the job</li><li>Minimum of a Bachelor’s Degree, preferably with a Business, Technical and /or Supply Chain focus.</li><li>Minimum of 8 years’ experience in Supply Chain Operations.</li><li>Project management experience preferred.</li><li>Experience with Six Sigma/Process excellence tools, training or certification.</li><li>Shipment of Hazardous Material transportation certification.</li><li>APIC’s certification preferred.</li><li>Knowledge Proficiency in a body of information required for the job e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.</li><li>Knowledge of US and international transportation and distribution practices.</li><li>Knowledge of Code of Federal regulations Title 21 part 210 and 211, and DEA rules and regulations for distribution/storage/manufacture of controlled substances is a must.</li><li>Must have working knowledge of serial shipping container code (SSCC).</li></ul> Skills &amp; Abilities: <ul><li>Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.</li><li>Strong communication, collaboration, and organizational skills.</li><li>Results oriented - identifies issues and drives the decision process.</li><li>Ability to effectively challenge assumptions/decisions and support the minority viewpoint when needed.</li><li>Influence management – ability to work cross-functionally at all levels.</li><li>Creative innovation skills, excellent influencing skills, and strong design and visualization capability.</li><li>Deals well with conflict – negotiator, mediator.</li><li>Collaborates with team members on plans (and holds team members accountable).</li><li>Good problem-solving skills, sound judgment.</li><li>Take decisive action and deliver tangible results in a fast-paced cross-functional organization and highly competitive industry.</li></ul> Physical Requirements: <ul><li>Physical &amp; mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.</li><li>Able to sit and stand for up to 8 hours.</li><li>Able to walk through production areas.</li><li>Able to lift up to 30 lbs.</li><li>Distribution Operations Oversee all distribution operations for the warehouse, assuring timely accurate and cost-effective deliveries.</li><li>Direct cycle counting procedures to maintain accurate inventory. Review all transportation billing for accuracy before sending to AP.</li><li>Execute contract customer shipments to ensure timely deliveries. Maintain and administers all departmental policies, SOP’s and training.</li><li>Compliance and Audit Ensure compliance with all safety and regulatory guidelines.</li><li>Maintain the warehouse, shipping/receiving areas and distribution center in audit ready condition including upholding a strict level of cleanliness.</li><li>Ensure that all documentation is up to date and easily accessible.</li><li>Maintain an on-going relationship with Supply Chain for inventory and shipments issues.</li><li>Must be current with all federal counterfeit drug regulations, E-pedigree state laws and ASN rules and regulations with the wholesalers.</li><li>Cross-Functional Support Maintain training records for all colleagues in your organization and ensure 100% compliance to training guidelines.</li><li>Work with finance on a monthly basis to ensure all shipments and customer orders have been processed are resolved for months end.</li><li>Works closely with Quality and Regulatory on all related issues. anticipates in audits as needed.</li></ul>

Role Description: <ul><li>Job Summary The Operations Supervisor is responsible for overseeing solid dosage pharmaceutical manufacturing and packaging activities during 2nd shift operations, 3:15pm to 11:45pm.&nbsp;</li><li>This role ensures that all production operations comply with cGMP, safety standards, and production schedules.</li><li>The operations supervisor will lead and support a team of leads and operators ensuring high quality output, operational efficiency, and a safe working environment.</li><li>Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&amp;L responsibility, etc.</li><li>Oversees and coordinates Manufacturing and Packaging operations.&nbsp;</li></ul> Responsibilities: Key Accountabilities: <ul><li>Accountability Lead and supervise operations in solid dosage manufacturing and packaging to ensure adherence to Master Formula and Master Packaging Records, SOP’s, and regulatory requirements (FDA, etc.).</li><li>Communicate with department leadership, set the shift schedule, and conduct shift huddle/communication at start of shift to ensure effective communication between shifts.</li><li>Ensure timely execution of production schedules.</li><li>Monitors manufacturing and packaging processes to ensure schedule is met within standards.</li><li>Review and complete shift documentation, including batch documentation, logbooks, etc.</li><li>Coordinate with Engineering and Quality Assurance to address any equipment issues that occur during the shift Support investigations for deviations that occur during the shift.</li><li>Assist in determining and implementing CAPA.</li><li>Provide training, guidance, and performance feedback for shift employees.</li><li>Ensure training requirements are met.</li><li>Support employee development and cross-training.</li><li>Executes procedures to complete tasks in a compliant and safe manner.</li></ul> Continuous Improvement <ul><li>Captures and reports metrics; troubleshoots downtime to increase operational efficiency.</li><li>Lead or participate in Continuous Improvement projects.</li><li>Troubleshoots and resolves process issues.</li></ul> Issues &amp; Deviations <ul><li>Performs defect evaluations and initiates production events.</li><li>Identifies, reports, and suggests resolutions for processing related issues.&nbsp;</li><li>Assists in the investigation of unplanned deviations.</li></ul> Teamwork and Collaboration <ul><li>Provides priorities for the off-shift operations, focusing resources on priority products.</li><li>Interfaces with supervisors and/or Quality personnel to inform of deviations or other line issues.</li><li>Continuous Training Ensures personnel are current with training requirements.</li><li>Stays current on SOPs and cGMPs.</li><li>Continuous Safety &amp; Compliance Contribute to safety audits.</li><li>Ensures out manufacturing/packaging activities safely, as required, on a daily basis.</li><li>Follows all safety and compliance procedures and participates in required training.</li><li>Adheres to all cGMP compliance/regulatory mandates and quality requirements.</li><li>Participate in safety teams, start-up discussions, incident debriefs, etc.</li><li>Ensures compliance with SOPs, Policies and Procedures as required by the Company and regulatory agencies.</li><li>Misc Other related duties as assigned to meet departmental and Company objectives.&nbsp;</li></ul> Requirements: Qualifications Education &amp; Experience: <ul><li>Minimal acceptable level of education, work experience and certifications required for the job Bachelor’s degree in pharmacy, Chemistry, Engineering, or a related discipline preferred, relevant experience my substitute.</li><li>Minimum of 3 years supervisory experience in pharmaceutical solid dosage manufacturing/packaging.&nbsp;</li><li>Knowledge Proficiency in a body of information required for the job e.g.</li><li>Knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.</li><li>Thorough knowledge of cGMP and FDA regulations.</li><li>Thorough knowledge of manufacturing and packaging operations.&nbsp;</li></ul> Skills &amp; Abilities: <ul><li>Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.</li><li>Demonstrated leadership, communication, and decision-making skills.</li><li>Ability to oversee and manage the daily operations of manufacturing and packaging. Ability to monitors processes to ensure schedule is met within standards.</li><li>Ability to analyze metrics and troubleshoot downtime.&nbsp;</li><li>Effectively interfaces with Quality Assurance to inform of deviations or other line issues.</li><li>Demonstrates the ability to work in collaboration with others as a part of a team.</li><li>Ability to lead in Continuous Improvement projects.</li><li>Possess technical writing skills.&nbsp;</li><li>Physical Requirements Physical &amp; mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.</li><li>Must be able to stand for long periods of time (8- or 12-hour shifts), lift at least 35 pounds, climb ladders, wear a dust mask or respirator and pass associated respirator tests and/or requirements, and be able to wear all required PPE, including safety glasses, ear plugs, and safety shoes.</li></ul>

Role Description: <ul><li>A concise overview of the job The Supervisor, Quality Control is responsible for overseeing the day-to-day operations of the QC raw material testing group.</li><li>Supervision and enforcing cGMP’s, GLP’s, conducting investigations, method transfers, verifications of compendia methods and training of new employees.</li><li>All incumbents are responsible for following applicable Division &amp; Company policies and procedures.</li><li>Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority (capital, operating, etc.), P&amp;L responsibility, etc.</li><li>Supervisory responsibilities within a single site.</li></ul> Responsibilities: <ul><li>QC Lab Management- Supervise day-to-day operations of QC Laboratory to ensure that cGMP’s, GLP’s and all other applicable compendial requirements are met.</li><li>Ensure that the testing is done as per the approved monograph procedures, investigate and take corrective actions, document investigation findings and coordinate the approval process of investigations.</li><li>Interact with Planning, Purchasing, Supply Chain, Production, QA for timely release of raw materials, excipient and packaging components.</li><li>Coordinate Analytical Methods Transfer projects. Identify and implement procedures to reduce cost of goods.</li><li>Develop systems and processes for proactive management of laboratory logistics and instrumentation.</li><li>Oversee ordering of lab supplies in observance of Departmental Budget constraints.</li><li>Workload Management- Coordinate workload sharing with other groups in QC and develop action plans to improve the working environment and for maximization of laboratory efficiency.</li><li>Prepare monthly report of the issues, work done, any employee related issues and conduct bi-weekly audits of the analyst’s notebooks.</li><li>SOPs - Review/update SOP’s, procedures and monographs for the QC Group as needed.</li><li>Review and comment on the articles affecting QC in the USP Supplements and Pharmacopeial Forums.</li><li>Conduct periodic audits of the analyst notebooks and instrument logbooks to ensure compliance of cGMP’s.</li><li>Staff Development-Evaluate potential candidates for QC; performance evaluation of direct reports.</li><li>Provide training in all procedures/instrumentation/techniques, including but not limited to HPLC, UV-Vis, IR, and Raw Material, Finished Product, Stability testing. 15% Total	100% Qualifications&nbsp;</li></ul> Requirements: Education &amp; Experience <ul><li>Minimal acceptable level of education, work experience and certifications required for the job</li><li>BS in chemistry or related discipline with 10+ years’ experience in pharmaceutical testing OR MS in Chemistry or related discipline with 7+ years’ experience in pharmaceutical testing.</li><li>3+ years’ QC lab supervisory experience in pharmaceutical industry.</li><li>Demonstrated management and leadership experience with strong interpersonal and influencing skills.</li></ul> Knowledge&nbsp; <ul><li>Proficiency in a body of information required for the job e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.</li><li>Expert knowledge of applicable safety and standards guidelines, such as SOP, cGMP, GLP, DEA regulations and/or SDS.</li><li>Strong knowledge and proficiency required with laboratory techniques/instruments, such as HPLC, GC, analytical balance, pipette, burette, oven, UV-vis spectrophotometer, dissolution tester, pH meter, etc.</li><li>Strong knowledge and proficiency preferred with Empower, Track Wise and Labware LIMS.</li></ul> Skills &amp; Abilities	 <ul><li>Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.</li><li>Organizational Support- Follows policies and procedures; completes administrative tasks correctly and on time; supports organizations goals and values; benefits organization through outside activities; supports affirmative action and respects diversity.</li><li>Leadership - Exhibits confidence in self and others; inspires and motivates others to perform well; effectively influences actions and opinions of others; accepts feedback from others; gives appropriate recognition to others.</li><li>Supervising People- Includes staff in planning, decision-making, facilitating and process improvement; takes responsibility for subordinates activities; is available to staff; provides regular performance feedback; develops subordinates skills and encourages growth; solicits and applies customer feedback (internal and external); fosters quality focus in others; improves processes, products and services.; continually works to improve supervisory skills.</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>Demonstrated flexibility in carrying out varied assignments in a high-quality work environment.</li><li>Excellent written and oral communications skills with a strong emphasis on organizational capabilities.</li></ul> Physical Requirements	 <ul><li>Physical &amp; mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.</li><li>Employee is frequently required to use hands to handle or feel.</li><li>The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision and color vision.</li><li>The noise level in the work environment is usually moderate.</li><li>The work environment is representative of a group laboratory environment.</li><li>QC Lab Management, Workload Management, SOPs, Staff Development</li></ul>

Responsibilities: <ul><li>Material/Product Review &amp; Release:</li><li>Review raw material and finished product testing result records, including Certificates of Analysis (C of A), Certificates of Conformance (C of C), and laboratory reports to confirm accuracy.&nbsp;&nbsp;</li><li>Determine the acceptability of materials/products for release based on compliance with specifications and testing results.&nbsp;&nbsp;</li><li>Perform ERP transactions for the release, hold, or rejection of raw materials and finished products.&nbsp;&nbsp;</li><li>Prioritize raw material review and release based on production scheduling requirements.&nbsp;&nbsp;</li></ul> Requirements: <ul><li>Minimum 5-12 years of experience in the pharmaceutical industry related to material/product review, release, and laboratory functions.&nbsp;&nbsp;</li><li>Expertise in reviewing and managing GMP documents, raw material and product testing, and quality systems.&nbsp;&nbsp;</li><li>Proficiency with laboratory systems and software tools such as LIMS, SAP, and EMPOWER.&nbsp;&nbsp;</li><li>Strong understanding of regulatory guidelines, including FDA, EMA, and ICH, as well as industry standards and best practices.&nbsp;&nbsp;</li></ul>

Role Description: <ul><li>Position Overview: We are seeking a skilled and detail-oriented Electrical/Controls Technician to join our pharmaceutical operations team. </li><li>The successful candidate will be responsible for the installation, maintenance, troubleshooting, and repair of electrical control systems used in pharmaceutical manufacturing and packaging processes. </li><li>This role is critical to ensuring operational efficiency, product quality, and compliance with regulatory standards.&nbsp;</li></ul> Responsibilities:&nbsp; Installation and Maintenance:&nbsp; <ul><li>Install and maintain electrical control systems, PLCs (Programmable Logic Controllers), HMIs (Human-Machine Interfaces), and SCADA systems.&nbsp;</li><li>Perform routine preventive maintenance on electrical systems to minimize downtime and ensure continuous operation.&nbsp;</li><li>Test and validate electrical control systems during commissioning and upgrades.&nbsp;</li></ul> Troubleshooting and Repairs:&nbsp; <ul><li>Diagnose and resolve malfunctions in electrical systems, instrumentation, and automation equipment.&nbsp;</li><li>Utilize diagnostic tools, schematics, and software to identify root causes of system failures.&nbsp;</li><li>Repair or replace faulty components, including relays, sensors, actuators, and circuit boards.&nbsp;</li></ul> System Optimization:&nbsp; <ul><li>Program, configure, and optimize PLCs, HMIs, and VFDs (Variable Frequency Drives) to improve system performance and efficiency.&nbsp;</li><li>Assist in the design and implementation of new electrical control systems for process improvements and new projects.&nbsp;</li><li>Conduct system performance tests to ensure compliance with specifications and regulatory requirements.&nbsp;</li></ul> Documentation and Compliance:&nbsp; <ul><li>Maintain accurate documentation of electrical control systems, including wiring diagrams, and maintenance logs.&nbsp;</li><li>Ensure all activities comply with GMP (Good Manufacturing Practices), FDA, and other regulatory guidelines.&nbsp;</li><li>Participate in audits and provide technical expertise regarding control systems and maintenance records.&nbsp;</li></ul> Safety and Training:&nbsp; <ul><li>Adhere to safety protocols and ensure that all electrical work complies with NFPA, OSHA, and company standards.&nbsp;</li><li>Conduct risk assessments for electrical systems and implement appropriate safety measures.&nbsp;</li><li>Provide technical training to maintenance personnel on electrical systems and best practices.&nbsp;</li></ul> Collaboration:&nbsp; <ul><li>Work closely with engineering, production, and quality assurance teams to ensure electrical systems support manufacturing requirements.&nbsp;</li><li>Communicate effectively with equipment vendors and contractors for system upgrades and troubleshooting.&nbsp;</li></ul> Requirements: <ul><li>Education: Associate’s degree in electrical engineering, electronics, or a related field.&nbsp;</li><li>Experience: Minimum of 3-5 years in electrical controls, automation, or instrumentation, preferably in a pharmaceutical or regulated industry.&nbsp;</li><li>Technical Skills: Proficiency in PLC programming (e.g., Allen-Bradley, Siemens).&nbsp;</li><li>Strong understanding of electrical schematics, control wiring, and instrumentation.&nbsp;</li><li>Familiarity with SCADA systems and industrial networks.&nbsp;</li><li>Knowledge of GMP and regulatory standards in the pharmaceutical industry.&nbsp;</li></ul> Certifications: <ul><li>Relevant certifications (e.g., Journeyman Electrician, ISA Technician Certification) are a plus.&nbsp;</li></ul> Key Competencies:&nbsp; <ul><li>Analytical problem-solving skills with attention to detail.&nbsp;</li><li>Ability to work independently and as part of a team.&nbsp;</li><li>Excellent communication and documentation skills.&nbsp;</li><li>Commitment to safety, quality, and regulatory compliance.&nbsp;</li></ul>

Role Description: <ul><li>The Lead Quality Specialist - Investigator serves as the primary investigator for Out of Specification (OOS), Out of Trend (OOT), Non-Official Events (NOE), and other laboratory investigations within the Quality Control (QC) department.</li><li>This role is responsible for initiating, conducting, and closing laboratory investigations while collaborating with cross-functional teams to ensure accurate root cause analyses, effective Corrective and Preventive Actions (CAPAs), and adherence to compliance requirements.</li><li>Frequent interaction with QC, QA, Manufacturing, and other departments is essential to achieve timely investigation closure and process improvements.</li></ul> Scope of Authority <ul><li>Provides investigative and compliance support to the QC laboratory, with a focus on maintaining quality standards and supporting cross-departmental collaboration.</li></ul> Responsibilities; 1. Initiation, Execution, and Closure of QC Lab Investigations (60%) <ul><li>Initiate and conduct OOS, OOT, and NOE investigations in alignment with procedural timelines.</li><li>Provide support and guidance to QC teams during execution, writing, and closure of investigations.</li><li>Conduct interviews with QC personnel to gather information and complete investigation reports in Trackwise.</li><li>Utilize laboratory software for root cause and impact analyses.</li><li>Conduct quality walkthroughs in the QC laboratory to identify and address compliance issues.</li><li>Regularly communicate with departmental leaders to provide updates on investigation progress and documentation needs.</li></ul> 2. Corrective and Preventive Actions (CAPAs) (30%) <ul><li>Collaborate with cross-functional teams to identify, implement, and monitor CAPAs within QC laboratories.</li><li>Assist with training, procedure updates, and monograph revisions based on investigation outcomes.</li><li>Provide recommendations for process improvements to support continuous improvement initiatives.</li></ul> 3. Compliance (10%) <ul><li>Identify compliance risks, propose remediation strategies, and lead the implementation of solutions.</li><li>Provide compliance expertise, training, and support to QC and other impacted departments.</li></ul> Requirements: Education &amp; Experience <ul><li>Bachelor’s degree in Chemistry, Biology, or Pharmaceutical Sciences.</li><li>Minimum of 4 years of experience in a pharmaceutical manufacturing environment.</li></ul> Knowledge <ul><li>Proficiency in HPLC, GC, and related chromatography methods and equipment.</li><li>Working knowledge of Chromatographic Data Systems (e.g., Empower preferred) and applications such as Trackwise.</li><li>Comprehensive understanding of QC lab testing and data integrity principles.</li><li>Familiarity with regulatory requirements, including 21-CFR-210, 21-CFR-211, ICH Guidelines, and Compendia standards (USP, EP, JP, etc.).</li></ul> Skills &amp; Abilities <ul><li>Strong technical writing and documentation skills.</li><li>Problem-solving and decision-making expertise.</li><li>Excellent communication skills with peers, chemists, and senior management.</li><li>Critical thinking and root cause analysis proficiency.</li><li>Customer and stakeholder focus, with a strong commitment to quality and integrity.</li><li>Physical &amp; Mental Requirements</li><li>Ability to sit, stand, walk, and use a computer for extended periods.</li><li>Exposure to moderate noise levels and various chemicals in an FDA- and DEA-regulated environment.</li><li>Ability to wear personal protective equipment (e.g., gloves, respirators).</li><li>Specific vision requirements include close vision and color vision.</li></ul>

Role Description:We’re looking for motivated, engaged people to help make everyone’s journeys better.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.Responsibilities: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.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.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.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.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.Prepares menu and food preparation reports by collecting, analyzing, and summarizing food, dining, and customer data and trends.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.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.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.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.Accomplishes culinary goals by accepting ownership for accomplishing new and different requests; exploring opportunities to add value to job accomplishments.Ensures quality production standards are followed and maintained. Ensures employees adhere to HACCP, FDA and safety regulations and compliance with company policies and procedures.Trains and monitors employees on proper work procedures and production of products to ensure maximum productivity with minimum labor and food expenses.Assists in the development and training of cooks as required.Prepares administrative reports as required.Ensures maximum productivity and labor costs are maintained according to financial requirements. Monitors daily manpower planning and employee turnover. Responsible for employee retention.Ensures meal cycles are communicated in a timely and accurate basis. Monitor yields of products to ensure maximum usage.Works with management staff to improve performance of the unit.Ensures Menu presentations are properly planned, set up, and specifications reviewed to ensure compliance.Maintains labor requirements, food costs, overtime, and all productivity requirements.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.Ensures all products are cooked at required temperature according to airline and food safety specification, etc.Responsible for coaching, counseling and preparing corrective action for employees.Completes all company required training including but not limited to ServSafe Sanitation Manager Certification.Requirements:Education:Associate Degree or Bachelor Degree in the Culinary Arts or a related field, (formal culinary education) required or at least 4 years of experience in an Executive Chef role.Work Experience:Minimum 10 years of experience as a Chef required.Minimum of 4 years of experience as an Executive Chef required.Minimum of 1-3 years of supervisory experience working in a high volume, manufacturing, food production, and restaurant or catering environment required.In-flight catering experience or experience in a high-volume food service environment required.Halal: 5 years of experience required.ServSafe Certified preferred.

Responsibilities:The Chemist I, under direct supervision, learns and performs QC laboratory chemical analyses of raw materials, in-process materials, stability and finished products, and testing to support process validation.May participate in investigations.Learns and stays current with regulatory guidances and compendia relevant to laboratories and pharmaceutical manufacturing.Conducts routine laboratory analyses: finished product testing, stability testing, raw material testing, cleaning verification testing and manufacturing in-process testing.Typical activities may include buffer/solution preparation, standard preparation and operating analytical instruments: HPLC, UV-Vis, FT-IR, GC and dissolution tester, melting point apparatus, viscometer, Karl Fischer titrator, pH meter, analytical balance, etc. Uses laboratory software for analyses.Provides general laboratory support such as routine instrument cleaning/preventative maintenance/calibration, sample receiving, chemical inventory, document filing and housekeepingCleans lab working surfaces and disposes of any excess chemicals, solutions, solvents, etc. in the special waste containers for each class of waste chemicals.Under close supervision, learns to troubleshoot basic instrument problems.With guidance, participates in OOS/OOT/NOE and other investigations.Elevates questionable sample results, OOS, and aberrant results immediately to Supervisor.May assist in drafting, editing, and reviewing SOPs and laboratory investigations.Maintains assigned training records current and in-compliance.May assist in the training of less senior laboratory staff.Performs assigned work in a timely and safe manner conforming to regulatory, company and compendiaI requirements within pharmaceutical manufacturing setting.Document accurately data generated in notebooks/worksheets/LIMS in compliance with SOPs.Follows internal processes related to controlled substances continuous.Follows EH&S procedures to ensure a safe work environment.Follows all applicable safety and standards guidelines, such as SOPs, cGMP, DEA regulations good documentation practice and/or MSDS continuous.Requirements:Minimal acceptable level of education, work experience and certifications required for the job.Bachelor of Science Degree in chemistry, chemical engineering or related field with analytical chemistry coursework required. Some pharmaceutical laboratory experience preferred.Proficiency in a body of information required for the job.e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.Proficiency with various laboratory techniques/instruments: HPLC, UV-Vis, FT-IR, GC and dissolution tester, melting point apparatus, viscometer, Karl Fischer titrator, pH meter, analytical balance, etc. Basic knowledge of wet chemistry techniques.Knowledge of applicable safety and standards guidelines: SOP, cGMP, GLP, DEA regulations and/or MSDS.Competency in Microsoft Office Suite.Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.Ability to display and analyze data in a logical manner.Good verbal and written communication skills as well as good computer skills.Attention to details and accurate record keeping.Establish and maintain cooperative working relationships with othersSolid organizational skills.Ability to take initiative, set priorities and follow through on assignments.Physical & mental requirements e.g., lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.Extended periods of sitting, standing, walking, reaching, climbing/balancing, kneeling/crouching/crawling, looking at monitor for extended periods, moderate noise levels and potential business travel. Work is in an FDA and DEA-regulated pharma lab environment with risk of exposure to various chemicalsMust occasionally lift and/or move up to 15-25 lbs.Ability to wear personal protective equipment, including respirators, gloves, etc. Specific visions abilities are required by this job include close vision and color vision.Ability to occasionally tolerate significant differences in temperature and/or humidity for short periods.

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10 fda Jobs found

Mgr II Qlty & Reliability Engineering

Head of Commercial Operations

Warehouse Supervisor/Manager

Operations Supervisor

Quality Control Supervisor

Analytical Quality Assurance Specialist

Electrical/Controls Technician

Lead Quality Specialist - Investigator

Halal Executive Chef

QC Chemist I

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10 fda Jobs found

Mgr II Qlty & Reliability Engineering

Head of Commercial Operations

Warehouse Supervisor/Manager

Operations Supervisor

Quality Control Supervisor

Analytical Quality Assurance Specialist

Electrical/Controls Technician

Lead Quality Specialist - Investigator

Halal Executive Chef

QC Chemist I

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