QC Microbiologist II

Employer
Sun Pharmaceuticals, Inc
Location
Billerica, Massachusetts, US
Salary
Competitive
Posted
May 07, 2021
Closes
Jun 03, 2021
Ref
2148851587
Discipline
Other
Employment Type
Full time
Salary Type
Salary
QC Microbiologist II
Location MA, Billerica
Job Category Quality Control
Employment Duration Full time
Perform GMP testing of raw materials, in-process and finished products, stability samples, and non-routine sample analyses per established procedures and methodology
- Record GMP data, monitors and evaluates QC systems and equipment
- Implement improvements to procedures, and revises SOP's and GMP documentation as required
- Interact with internal and external auditors including government agencies and contract manufacturing representatives
- Perform sterility and endotoxin testing for release, stability, and validation for raw materials, in-process and final products
- Maintain Sterility and Endotoxin testing areas in a state of cGMP compliance
- Perform and review growth promotion testing data for qualification of microbial culture media
- 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 evaluates systems, equipment (i.e. water systems, environmental chambers, sample collection and testing instruments/equipment)
- Maintain records in paper based or computer based systems
- Author and execute method validation/suitability protocols related to product testing
- Author summary reports for executed method validation/suitability protocols
- Author deviation reports and microbiological assessment reports related to departmental activities and product testing
- Review Microbiology testing data as required
- Coordinate receipt of raw material, in-process and final product samples for testing
- Maintain metrics for receipt and processing of samples for microbiology testing
- 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
- Perform other duties as assigned
Qualifications
- 2-4 years related experience in a Pharmaceutical/drug (FDA Regulated) industry preferred
- ???????BS in Microbiology or related field 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

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