ProStaff 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

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.

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