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Senior Associate, Quality Assurance
Billerica, Massachusetts · Biotech/PharmaceuticalProStaff Workforce Solutions is seeking a Senior Associate, Quality Assurance for one of the largest pharmaceutical companies in Billerica, MA. Our client is one of the leading pharmaceutical companies in the region and specializes in the production and sale of radiopharmaceuticals and formulation, analytical methods development and production of parenteral drugs. If you believe you are qualified, we would be excited to connect and discuss this opportunity in more detail.
Full-time Onsite
Direct Hire
Job Summary
Performs QA review of testing records of raw materials, in-process and finished products, stability samples, and non-routine sample analyses per established procedures and methodology.
Area Of Responsibility
Work Conditions:
Physical Requirements:
Travel Estimate
Up to 5%
Qualifications
Our client offers a competitive compensation package as well as an excellent benefits package for eligible candidates.
Please visit us at https://www.prostaffworkforce.com/ to explore all opportunities.
#IND1
Full-time Onsite
Direct Hire
Job Summary
Performs QA review of testing records of raw materials, in-process and finished products, stability samples, and non-routine sample analyses per established procedures and methodology.
Area Of Responsibility
- QC Testing data review of products, raw materials, stability lots
- Oversee and continuously improve FDA / regulatory compliant Quality System for QC laboratory system
- Plan, direct and coordinate QC batch record review, logbook review, QC test review, and lot disposition activities
- Support any regulatory inspections or internal/external audits
- Perform review of release, stability, validation, analytical quality control tests on raw materials, in-processing and final products
- Conduct, document and follow up on OOS and OOT and Out of Calibration investigations
- Conduct, document and follow up on Lab Events
- Review calibration, monitor and evaluate systems and equipment (i.e. water systems, environmental chambers, analytical instrument/equipment)
- Review IQ/OQ and PQ protocols for analytical instruments
- Maintain laboratory in cGMP compliance and conduct inspections and internal audits
- Record and review GMP data, monitor and evaluate QC systems and equipment, recommend improvements to procedures, and revise GMP documentation as required.
- Serve as a leader within the QC group and as a knowledge resource (data review, electronic review, data integrity, GDP) within the company
- Any Other duties as assigned
Work Conditions:
- Office
- Lab
- Noise, heat, open flame and radiation in specific areas requiring appropriate safety equipment (i.e. gloves, lab coat, safety glasses and respirator)
- Work with non-hazardous and hazardous chemicals, toxic metals, cryogenic gases and radioactive materials.
- Exposure to or use of syringes and needles
Physical Requirements:
- Stand, walk, sit, use hands and fingers to handle or feel, reach with hands and arms, climb or balance, stoop, kneel, crouch or crawl, hear and talk
- Close vision
- Lift up to 10 lbs.
- Operates Computer/office machines
Travel Estimate
Up to 5%
Qualifications
- B.S. or equivalent experience
- Minimum 5-7 years of related experience
- Working knowledge of cGMP/GLP
- Fundamental knowledge of chemical principles and analytical instrumentation
- Proficient with wet chemical methods and tests (USP, ACS, Titration, Limit tests, etc.)
- Proficient knowledge of basic and complex laboratory instrumentation (theory, function, basic and complex troubleshooting)
- Competent computer skills including Microsoft Office and instrumentation control software programs
- Experience with qualitative and quantitative analysis using good analytical laboratory practices
- Proficient in use of Ultraviolet/Visible (UV/VIS) Spectrometer, Conductivity Meter,, pH Meter, Karl Fischer Titrator, High temperature furnaces and oven, Fume hoods, Stirrer/hot plates, Propane burners, Compressed Gas Regulators and Cylinders, Infrared (IR), Gamma Ray Spectrometer, Flame Atomic Absorption (AA), Scanning Ultraviolet/Visible (UV/VIS) Spectrometer, Polarograph, Coulometer, High Pressure Liquid Chromatography (HPLC), and Gas Chromatography.
- Excellent oral, written and interpersonal communication skills
- Ability to follow specific instruction (i.e. written SOPs)
Our client offers a competitive compensation package as well as an excellent benefits package for eligible candidates.
Please visit us at https://www.prostaffworkforce.com/ to explore all opportunities.
#IND1