Senior Associate, Quality Assurance

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 OnsiteDirect Hire

Job SummaryPerforms 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 lotsOversee and continuously improve FDA / regulatory compliant Quality System for QC laboratory systemPlan, direct and coordinate QC batch record review, logbook review, QC test review, and lot disposition activitiesSupport any regulatory inspections or internal/external auditsPerform review of release, stability, validation, analytical quality control tests on raw materials, in-processing and final productsConduct, document and follow up on OOS and OOT and Out of Calibration investigationsConduct, document and follow up on Lab EventsReview calibration, monitor and evaluate systems and equipment (i.e. water systems, environmental chambers, analytical instrument/equipment)Review IQ/OQ and PQ protocols for analytical instrumentsMaintain laboratory in cGMP compliance and conduct inspections and internal auditsRecord 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 companyAny Other duties as assigned

Work Conditions:

OfficeLabNoise, 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 talkClose visionLift up to 10 lbs.Operates Computer/office machines

Travel EstimateUp to 5%

Qualifications

B.S. or equivalent experienceMinimum 5-7 years of related experienceWorking knowledge of cGMP/GLPFundamental knowledge of chemical principles and analytical instrumentationProficient 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 programsExperience with qualitative and quantitative analysis using good analytical laboratory practicesProficient 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 skillsAbility 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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