Microbiology Analyst I at SUN PHARMA in Billerica, MA

Summary: SUN PHARMA is a pharmaceutical company seeking a Microbiology Analyst I to perform GMP testing of raw materials and products. The role involves recording data, recommending procedure improvements, and conducting microbial testing to ensure compliance with quality standards. Responsibilities: - 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 - Other duties as assigned Required Qualifications: - BS in Microbiology or relevant experience required - 0-2 years related experience in a Pharmaceutical/drug (FDA Regulated) industry preferred - 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 Required Skills: GMP testing, Microbiology testing, Endotoxin testing, Method validation, Sterility testing, Bioburden testing, Microbial identification, Growth promotion testing, Environmental monitoring testing, cGMP knowledge, GLP knowledge, SOP compliance, Word processing, Spreadsheets Benefits: Annual Performance Bonus Plan, Medical, dental and vision coverage, Life insurance, Disability insurance, 401(k) savings plan, Flexible spending accounts, Employee assistance program, Various paid time off benefits, including vacation time and sick time