ProStaff Workforce Solutions is seeking a Sr QC Analyst 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.

Please visit us at https://www.prostaffworkforce.com/ to explore all opportunities.

Full time Onsite
Direct Hire
Pay Rate: DoE

Job Summary
Performs GMP testing of raw materials, in-process and finished products, stability samples, and non-routine sample analyses per established procedures and methodology. Monitors and evaluates systems, equipment, records and trends data. Reviews and revises documentation (i.e. SOPs). Works under limited supervision following established procedures.

Job Description:

• Perform release, stability, validation, analytical quality control tests and assays on raw materials, in-processing and final products following GLPs
• Perform quality control tests and assays including USP test methods and EP test methods
• Conduct, document and follow up on assay issues, failures and complaint investigations (Trackwise)
• Calibrate, monitor, maintain and evaluate systems and equipment (i.e. water systems, environmental chambers, analytical instrument/equipment)
• Maintain data in manual or computer based logs following GDPs
• Develop, author, and execute instrument IQ/OQ and PQ protocols
• Maintain major laboratory programs (i.e. calibration program, reference standard program)
• Serve as liaison to service, calibration and technical representatives
• Send samples to contract laboratories and collect test data
• Wash glassware, prepare reagents, solutions, equipment for chemical tests and assays
• Maintain laboratory in cGMP compliance and conduct internal lab inspections
• 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 a knowledge resource within the company
• Provide mentoring and training to junior analysts on laboratory tests, skills, and lab processes
• Perform monthly equipment/instrument maintenance and cleaning
• Follow work-flow procedures from receiving test samples, monitoring inventories, to waste disposal
• Train towards Visual Inspection qualifications
• Other duties as assigned

Required Qualifications:

• B.S. or equivalent experience
• Minimum 5-7 years of related experience
• Background as a Lead Investigator
• Experience in Trackwise, Novatech, and Empower software
• Experience with qualitative and quantitative analysis using good analytical laboratory practices
• Proficient with wet chemical methods and tests (USP, ACS, Titration, Limit tests, etc.)
• Proficient in use of Balances, Ultraviolet/Visible (UV/VIS) Spectrometer, Conductivity Meter, TOC Meter, pH Meter, Autotitrator, Karl Fischer Titrator, High temperature furnaces and oven, Fume hoods, Stirrer/hot plates, Propane burners, Compressed Gas Regulators and Cylinders, Melting Point, Infrared (IR), Gamma Ray Spectrometer and RCP assays, Flame Atomic Absorption (AA), Polarograph, Osmometer, High Pressure Liquid Chromatography (HPLC), Gas Chromatography (GC)
• Proficient knowledge of basic and complex laboratory instrumentation (theory, function, basic and complex troubleshooting)
• Proficient computer skills including word processing, spreadsheet, and instrumentation control software programs
• Able to perform standard and non-standard analytical techniques to analyze product
• Able to troubleshoot and repair complex instrumentation
• Working knowledge of cGMP/GLP
• Excellent oral and written and interpersonal communication skills
• Fundamental knowledge of chemical principles and analytical instrumentation
• Ability to follow specific instruction (i.e. written SOPs)
• Strong analytical skills with attention to detail

Our client offers a competitive compensation package as well as an excellent benefits package for eligible candidates.


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