QC Microbiologist I

Job DescriptionProStaff Workforce Solutions is seeking a QC Microbiologist I 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.

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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.

Area of Responsibility
• Record GMP data, monitor and evaluate QC systems and equipment
• Recommend improvements to procedures, and revise SOPs and GMP documentation as required
• Interact with internal and external auditors including government agencies and contract manufacturing representatives
• Perform release, stability, validation and complaint follow-up assays on raw materials, in-process and final products
• Perform microbial identification related to product and environmental testing
• Perform sampling of raw materials as required for QC testing
• Perform routine quality control testing as required and monitors or evaluate systems, equipment (i.e. water systems, environmental chambers, sample collection and testing instruments/equipment)
• Maintain records in paper based or computer based systems
• Execute method validation protocols related to product testing
• Author summary reports for executed method validations
• Author deviation reports and microbiological assessment reports related to departmental activities and product support
• Provide technical input on product testing issues and instrumentation/equipment
• Serve as liaison to service, calibration and technical representatives
• Conduct and document assay failure and complaint investigations
• Ensure that laboratory is in cGMP compliance and conduct inspections

Required Qualifications:
• B.S. in Microbiology required
• Experience in pharmaceutical microbiology and microbiology testing not limited to endotoxin, method validation, sterility, bioburden, microbial identification, growth promotion and environmental monitoring testing; ability to perform standard and non-standard microbiology techniques to analyze product
• Excellent verbal, written and interpersonal communication skills
• Proficient at following specific instruction (i.e. written SOPs)
• Working knowledge of cGMP/GLP
• Good computer skills including word processing and working with spreadsheets
• Stand, sit, walk, use hands and fingers to handle or feel, reach with arms and hands, talk or hear, stoop, kneel, crouch or crawl
• Close vision; depth perception; ability to adjust focus
• Use of repetitive motion
• Able to operate computer/office machines
• Lift up to 25 lbs

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

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