QC Supervisor

Business Development Manager

QC Chemist I

Quality Assurance Associate

Business Analyst Lead - Data Modelling

Specialist, DEA Compliance

Senior Engineer- V&V

Sous Chef

Responsibilities: <ul><li>Oversee physical/chemical/microbiological testing and analyses of pharmaceutical raw materials, excipients and finished drug products, including release, stability testing, cleaning verification test, and in-process testing.</li><li>Supervise daily work of Chemists, Microbiologists and Technicians; provide guidance and directions when necessary. Conduct lab investigations and prepare deviations as needed.&nbsp;&nbsp;</li></ul> Testing: <ul><li>Execute work schedule, review analysts’ notebooks and supervise analysts in day-to-day operations to ensure the compliance of SOP, cGMP, GLP, DEA regulations and/or MSDS.</li><li>Understand analytical instrument operation/maint. of HPLC, UV-Vis, FT-IR, GC, dissolution tester, melting point apparatus, viscometer, Karl Fischer titrator, pH meter, analytical balance, etc. Expert in analytical instrumentation to assure quality of test results.</li><li>Review notebooks and instrument logbooks. Release test results to QA or other departments in a timely manner.</li><li>Ensure timely completion of stability testing, provide data to regulatory groups, and conduct data trending during product shelf life.</li><li>Perform methods development, transfer, verification and validation activities.&nbsp;</li><li>Coordinate and assist with evaluation of Process Validations studies.&nbsp;&nbsp;&nbsp;</li></ul> Documentation Practice, Training and Compliance: <ul><li>Ensure work of staff is in compliance with good documentation practices per companys SOP and cGMP regulations in the laboratory.&nbsp;&nbsp;</li><li>Prepare and review laboratory documents such as Laboratory Deviations, Investigations, and Test Methods in a timely manner.</li><li>Enforce all applicable safety and standards guidelines, DEA regs and/or MSDS in lab. Ensure analysts are trained properly before they conduct corresponding testing.</li></ul> Lab Maintenance: <ul><li>Perform housekeeping on regular basis. Oversee general lab support; sample receiving, chemical inventory and document filing.</li><li>Enforce safety by ensuring wearing of lab coat, safety shoes, safety glasses while in lab.</li><li>Monitor ordering of lab supplies.</li><li>Enforce the control and management of controlled substances.&nbsp;&nbsp;</li></ul> Staff Development:&nbsp; <ul><li>Evaluate potential candidates for QC; prepare annual performance evals. for chemists.&nbsp;&nbsp;&nbsp;</li><li>Prepare chemists and laboratory for FDA and other compliance audits.</li><li>Ensures adequate resources are trained to support compliance and business initiatives.</li></ul> Requirements: Education &amp; Experience: <ul><li>BS in chemistry, biochemistry, pharmacy, or related discipline. Advanced degree a plus.</li><li>7+ years of experience in pharmaceutical laboratory.</li><li>2+ year QC supervisory experience preferred.</li></ul> Knowledge: <ul><li>Working knowledge of applicable safety and standards guidelines, such as SOP, cGMP, GLP, DEA regulations and/or MSDS.</li><li>Proficiency required with laboratory techniques/instruments, such as pipette, burette, oven, UV-vis spectrophotometer, dissolution tester, pH meter, HPLC or GC and analytical balance, etc.</li></ul> Skills &amp; Abilities: <ul><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; open to other ideas and tries new things.</li><li>Planning/Organizing – Prioritizes/plans work; uses time efficiently; plans for additional resources; sets goals/objectives; organizes/schedules other people and tasks; develops realistic action plans.</li><li>Safety and Security - Observes safety and security procedures; determines appropriate action beyond guidelines; reports potentially unsafe conditions; uses equipment and materials properly.</li><li>Dependability - Follows instructions, responds to management direction; takes responsibility for own actions; keeps commitments; commits to long hours of work when necessary to reach goals; completes tasks on time or notifies appropriate person with an alternate plan.</li><li>Initiative - Volunteers readily; undertakes self-development activities; seeks increased responsibilities; takes independent actions and calculated risks; looks for and takes advantage of opportunities; asks for and offers help when needed.</li><li>Good verbal and written communications with basic computer skills.</li></ul> Physical Requirements: <ul><li>Extended periods of sitting, standing and walking; use hands to finger, handle, or feel objects, tools, or controls; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl; talk or hear; and taste or smell, looking at monitor, moderate noise levels and some bus. travel. Work is performed in a FDA and DEA-regulated pharmaceutical lab environment with risk of exposure to various chemicals.</li><li>Must occasionally lift and/or move up to 25 pounds. Lab coat and safety glasses required in work environment.&nbsp;</li><li>Specific visions abilities are required by this job include close vision and color vision.</li><li>The noise level in the work environment is usually moderate.&nbsp;</li><li>The work environment is representative of a group laboratory environment.&nbsp;</li></ul>

Responsibilities: <ul><li>Distributor management – Working with international distributors on business planning, sales initiatives and managing the P&amp;L for the business.</li><li>Forecasting and demand planning – Leads the demand planning process with distributors, which include sales analysis, demand forecasting to reflect sales &amp; marketing plans, and shipment planning.</li><li>Supply chain management - Liaise with supply chain team to reflect our demand forecasting to ensure the supply/shipment from difference sourcing locations globally.	Portfolio management – Addressing the sales opportunities we might have to accelerate growth across different consumer groups and channels in Malaysia and for the markets assigned.</li><li>Product importation and registration - Liaise with FSQ &amp; Regulatory team for any NPDs to complete internal product registration process and to complete the FDA registration for the market or to provide necessary documents to the distributors to complete the FDA registration.</li></ul> Requirements: <ul><li>Min 3-4 years’ experience in Sales from FMCG company&nbsp;</li><li>Bachelors Degree minimum</li><li>Very good command of English</li><li>Ability to work independently.</li><li>Distributor Management and Export business experience will be an advantage.</li></ul>

Responsibilities: <ul><li>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.</li><li>May participate in investigations.</li><li>Learns and stays current with regulatory guidances and compendia relevant to laboratories and pharmaceutical manufacturing.</li><li>Conducts routine laboratory analyses: finished product testing, stability testing, raw material testing, cleaning verification testing and manufacturing in-process testing.</li><li>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.&nbsp;</li><li>Uses laboratory software for analyses.</li><li>Provides general laboratory support such as routine instrument cleaning/preventative maintenance/calibration, sample receiving, chemical inventory, document filing and housekeeping</li><li>Cleans lab working surfaces and disposes of any excess chemicals, solutions, solvents, etc. in the special waste containers for each class of waste chemicals.</li><li>Under close supervision, learns to troubleshoot basic instrument problems.</li><li>With guidance, participates in OOS/OOT/NOE and other investigations.</li><li>Elevates questionable sample results, OOS, and aberrant results immediately to Supervisor.</li><li>May assist in drafting, editing, and reviewing SOPs and laboratory investigations.</li><li>Maintains assigned training records current and in-compliance.</li><li>May assist in the training of less senior laboratory staff.</li><li>Performs assigned work in a timely and safe manner conforming to regulatory, company and compendiaI requirements within pharmaceutical manufacturing setting.</li><li>Document accurately data generated in notebooks/worksheets/LIMS in compliance with SOPs.</li><li>Follows internal processes related to controlled substances continuous.</li><li>Follows EH&amp;S procedures to ensure a safe work environment.</li><li>Follows all applicable safety and standards guidelines, such as SOPs, cGMP, DEA regulations good documentation practice and/or MSDS continuous.</li></ul> Requirements: <ul><li>Minimal acceptable level of education, work experience and certifications required for the job.</li><li>Bachelor of Science Degree in chemistry, chemical engineering or related field with analytical chemistry coursework required.&nbsp;</li><li>Some pharmaceutical laboratory experience preferred.</li><li>Proficiency in a body of information required for the job.</li><li>e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.</li><li>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.&nbsp;</li><li>Basic knowledge of wet chemistry techniques.</li><li>Knowledge of applicable safety and standards guidelines: SOP, cGMP, GLP, DEA regulations and/or MSDS.</li><li>Competency in Microsoft Office Suite.</li><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>Ability to display and analyze data in a logical manner.</li><li>Good verbal and written communication skills as well as good computer skills.</li><li>Attention to details and accurate record keeping.</li><li>Establish and maintain cooperative working relationships with others</li><li>Solid organizational skills.</li><li>Ability to take initiative, set priorities and follow through on assignments.</li><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>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 chemicals</li><li>Must occasionally lift and/or move up to 15-25 lbs.</li><li>Ability to wear personal protective equipment, including respirators, gloves, etc.&nbsp;</li><li>Specific visions abilities are required by this job include close vision and color vision.</li><li>Ability to occasionally tolerate significant differences in temperature and/or humidity for short periods.</li></ul>

Responsibilities: <ul><li>Primary responsibilities of this role include the following:</li><li>With Supervision, review documents/records and provide batch release authorization to 3PL service provider for products manufactured outside of the US.</li><li>Support Drug Product Complaint management; forwarding to respective drug product manufacturing site and coordinate with corporate QA for investigations.</li><li>Support Drug Product Recall/Field alert management.</li><li>Assist with review of Quality Agreements.</li><li>For applicable products, coordinate with Contract Testing Laboratories for Analytical Method Transfer activities, Drug Product testing, any OOS results, and test method issues.</li><li>With supervision, review deviations/investigations related to the companys frontend products.</li><li>Assist with SOP management for the company’s US corporate office.</li><li>Support with quality matters for disposition of product returns.</li><li>Assist during FDA inspections and local regulatory inspections at the company’s US corporate office.</li></ul> Requirements: <ul><li>Excellent verbal and written communication skills are necessary.</li><li>With supervision and direction, effectively prioritizes competing tasks in a fast-paced and dynamic environment.</li><li>Motivated, results driven with attention to detail, accuracy and clarity.</li></ul> Qualifications:&nbsp; <ul><li>BS degree in Pharmacy, Chemistry, Biology or Microbiology is preferred. 1-2 years of Quality Assurance or related pharmaceutical industry experience is preferred.</li><li>Recent graduates will be considered for this role.&nbsp;</li></ul>

Role Description: <ul><li>As a Business Analyst Lead - Data Arhitect you will act as an expert between Finance and IT, leading data projects, refined mapping rules, and contributing to the data strategy.</li></ul> Responsibilities: <ul><li>Provide project-based technical leadership within the Business Systems team.</li><li>Work closely with a technical team to ensure that they have a clear understanding of requirements and to support them throughout the development process.</li><li>Interpret business challenges and develop best practices to maintain applications in various environments including traditional hosting providers, private cloud, and/or public cloud.</li><li>Manage the analysis, planning, requirement gathering and logical design of a software product by working with internal and external customers.</li><li>Use specialized expertise and advanced technical knowledge to recommend other key technologies required to support and improve the business process.</li></ul> Requirements: <ul><li>Master degree in Computer Science or related field.</li><li>5+ years of expertise in banking with exposure to regulatory requirements (Corep, Irrbb, Liquidity, etc.).</li><li>Expertise in Risk Management and Risk Calculations.</li><li>3-5 years of experience in the above areas within the Banking, Asset Management, Financial Services, Financial software or Consultancy.</li><li>Domain Expertise in Financial Instruments and Financial Markets.</li><li>IFRS knowledge would be considered an asset.</li><li>Knowledge in Data Modeling and Governance.</li><li>Extensive experience with End-to-End Testing and Test Data.</li><li>Possession of ACCA, CFA, FRM, or PRIMIA certifications would be considered an asset.</li><li>Previous exposure to one of WK data models (DF, FDA, RP) would also be considered an asset</li><li>Excellent communication (written and oral) skills – feeling comfortable with management reporting and presentations.</li><li>Advanced database knowledge (Oracle &amp; MS SQL Server).</li><li>Fluent in English, both written and spoken.</li></ul>

Role Description: <ul><li>The DEA Compliance Specialist, under general supervision, is knowledgeable on all matters of the DEA as it pertains to pharmaceutical testing, manufacturing and distribution of controlled substances.</li><li>Those matters include licenses, procurement, and movement of material, production, shipment and destruction.</li><li>Incumbent should also have the ability to interface with governmental agencies and represent the company as needed.</li></ul> Responsibilities: <ul><li>DEA coordinator for CII –CV controlled substances: manages/coordinates all DEA-related actives at site</li><li>Reviews and releases daily orders through Suspicious Order Monitoring System (SOMs) and assures compliance with Suspicious Orders Reporting (SORS)</li><li>Maintains Know your Customer (KYC) information</li><li>Conducts year‐end and biennial inventory and report ARCOS quarterly reporting &amp; cycle count inventory via DEA website</li><li>Coordinates all movement of controlled substances from manufacturing through analytical testing</li><li>Liaises with Procurement and DEA regarding import/export of controlled substance and completes necessary paperwork</li><li>Maintains compliance of all DEA, State, and Board of Pharmacy registrations</li><li>Coordinates all controlled substance destruction with QC, Environmental, Health &amp; Safety and Logistic departments</li><li>Works with Security department to maintain facility upgrades to security systems</li><li>Power of Attorney to sign DEA 222 form, responsible for completing, maintaining and tracking all DEA 222 forms</li><li>Responsible for submitting CII quota applications to DEA; maintain organized DEA files on related activities</li><li>Coordinates and documents DEA audits for sites and issues audit reports to management upon completion</li><li>Remains current on DEA regs in order to address organization business needs</li><li>Creates all destruction reports and coordinates pick ups for controlled destruction from MRB, line waste and lab waste.</li></ul> SOPs: <ul><li>Updates associated SOP’s related to job functions</li></ul> Supporting responsibilities:&nbsp; <ul><li>Back up to State Licensing associate</li><li>Participates and represents department at project meetings as required</li></ul> Requirements: Education &amp; Experience: <ul><li>Bachelor’s degree in a relevant field required</li><li>2+ years’ relevant work experience</li></ul> Experience with IQVIA SOM software preferred <ul><li>Working knowledge of GMP regulations and compliance issues</li><li>Strong knowledge of DEA and FDA regulations</li><li>Knowledgeable of production and production planning processes</li></ul>

Responsibilities: <ul><li>Lead/Execute, perform, summarize, and report out System verification test activities Medical devices: Which includes but not limited to:</li><li>Understand URS (User requirements) / System Requirements and prepare the System Level Test cases and Prepare test procedures.</li><li>Understand the product functionality and perform the Functional and Performance testing for the product.</li><li>Lead/Support and perform Design Verification activites</li><li>Drive/Perform Installation/Operational/Performance Qualification Protocols</li><li>Prepare Traceability Matrices and Final Reports.</li><li>Lead compliance/ closure of Regulatory and Quality requirements</li><li>Develop Test instructions and Test protocols.</li><li>Follow instructions clearly from Design engineers during Test execution.</li><li>Support Design engineers in Test fixture creation, building up &amp; tearing down Test equipment.</li><li>Plan Lab logistics and maintain the material supply for testing requirements.</li><li>Diagnose, isolate and investigate problem reports and defects.</li><li>Support to work with external test houses (such as EMI, EMC tests for electrical boards and full device) to define the test scope, author the test plans, test procedures, execute &amp; consolidate the reports.</li><li>Ensure good documentation and Good Manufacturing practices are followed in the Verification Process.</li><li>Experience in IEC basic safety, EMI-EMC standards</li><li>Interacts with design team to resolve tests-related technical issues.</li><li>Presents the findings / objective evidences and able to present with rationale with applicability / exclusions</li><li>Identify and report any quality or compliance concerns and take immediate corrective / Preventive action as needed.</li></ul>&nbsp;Requirements: <ul><li>Bachelors Degree in Mechanical engineering, Electrical Engineering, Software Engineering, Computer Science, Bio-Medical, Industrial Engineering or related field</li><li>Overall 6 to 10 yrs of experience with minimum 3 years in System Verification testing and performance testing.</li><li>Hands on experience in overall final design verification/validation(V&amp;V) testing of medical products.</li><li>Relevant technical testing/reliability experience in electro-mechanical, electrical testing of Medical Devices.</li><li>An understanding of test methods and processes as well as the methods used to verify product in the realms of; mechanical, electrical, functional testing environments.</li><li>Basic hands on experience in data analysis of Performance testing and Sample size calculations for variable/Attribute data</li><li>Experience in Tools like Minitab( Data Analysis) / JIRA ( Defect ) / ALM ( test Environment) etc.</li><li>Understanding of hardware and software product design methodologies and test practices.</li><li>Experience in medical device or similar product development, design verification/validation, system integration (hardware/Subsystem/Software), risk management, reliability engineering, process validation and Quality systems</li><li>Basic understanding of and adherence to FDA,MDD/MDR, ISO and IEC design control procedures, regulations and standards.</li><li>Self-motivated with good interpersonal skills.</li><li>Ability to follow instructions clearly.</li></ul>&nbsp;Preferred Candidates <ul><li>System V&amp;V Engineers with Experience in Infusion pumps design verification testing.</li></ul>&nbsp;

Job Summary: <ul><li>Reporting to the Executive Sous Chef or the Executive Chef for the unit, the Sous Chef, Operations assists the Executive Sous Chef Operations or the Executive Chef in designing and preparing meals for airline customers.&nbsp;</li><li>Provides culinary expertise and leadership; promotes quality food services and ensures food safety and sanitation requirements are followed.&nbsp;</li><li>Drives the food production effort with the assistance of Food Supervisors</li></ul> Responsibilities: <ul><li>Responsible for ensuring food specifications and labor objectives meet all Company and customer requirements</li><li>Supervises department for quality and quantity; ensures items are produced and dated according to specification, and coding system is adhered to correctly (i.e. - FDA, USDA, HAACP and other governmental regulations)</li><li>Keeps account of attendance, sets up paperwork, sets up each shift and assigns employees to specified sections (schedule optimization)</li><li>Orders raw material from storeroom and produces extra meals at last minute as needed</li><li>Prepares daily production sheet and assigns tasks to employees; works with and directs employees through the use of the production sheet and passenger counts</li><li>Responsible for all food items after requisitioning them from the storeroom; training and recurrent training of all employees on proper procedures of preparation</li><li>Ensures safety procedures are adhered to; maintain cleanliness through shift to ensure quality product</li><li>Manages daily production of hot and/or cold kitchens for quality and consistency</li><li>Ensures compliance with company Wage &amp; Hour policy, including ensuring employees get the rest &amp; meal breaks and ensuring company processes are followed.</li><li>Trains and monitors employees on proper work procedures to ensure maximum productivity with minimum labor and food expenses.&nbsp;</li><li>Monitors daily manpower planning and schedules employees.&nbsp;</li><li>Responsible for employee retention and reducing employee turnover.</li><li>Responsible for coaching, counseling and preparing corrective actions for employees in compliance with the applicable union/collective bargaining agreement(s).</li><li>Reviews and ensures employees in chain of command are in correct cost centers and correct job titles.</li><li>Reviews and ensures union represented employees’ pay rates are correct based on wage scales and seniority.</li><li>Employee must complete all company required training including but not limited to ServSafe&nbsp;</li><li>Compliance with all company required policies, procedures and processes including but not limited to required training&nbsp;</li></ul> Requirements: Education: <ul><li>Associates degree in the Culinary Arts or a Culinary Arts certification preferred.</li></ul> Work Experience: <ul><li>Minimum 1-3 years of experience as a Chef and/or Sous Chef required.</li><li>Minimum 7 years of experience as a cook required.</li><li>Previous supervisory experience working in a high volume, manufacturing, food production, restaurant or catering environment preferred.</li><li>In-flight catering experience or experience in a high-volume food service environment preferred.</li></ul>&nbsp;Job Skills: <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 team of 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. 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. Working knowledge of Microsoft Office products preferred.&nbsp;</li></ul>

Skills

Industry

Location

Jobtitle

8 fda Jobs found

QC Supervisor

Business Development Manager

QC Chemist I

Quality Assurance Associate

Business Analyst Lead - Data Modelling

Specialist, DEA Compliance

Senior Engineer- V&V

Sous Chef

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

EMPLOYER

TALENT

COMPANY

Contact Us

JOBS BY SKILLS

JOBS BY FUNCTION

JOBS BY INDUSTRY

JOBS BY LOCATIONS

MODEL JOBS

JOBS BY CITY

Skills

Industry

Location

Jobtitle

8 fda Jobs found

QC Supervisor

Business Development Manager

QC Chemist I

Quality Assurance Associate

Business Analyst Lead - Data Modelling

Specialist, DEA Compliance

Senior Engineer- V&V

Sous Chef

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

EMPLOYER

TALENT

COMPANY

Contact Us

JOBS BY SKILLS

JOBS BY FUNCTION

JOBS BY INDUSTRY

JOBS BY LOCATIONS

MODEL JOBS

JOBS BY CITY

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