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Sr Microbiologist

Company: ProStaff Solutions
Location: Billerica
Posted on: June 20, 2022

Job Description:

Direct Hire
Job Summary:Oversee day to day operations of the QC Microbiology Laboratory. Ensure that required microbiology activities related to supporting manufacturing of aseptically processed pharmaceuticals are performed in compliance with company policies and procedures and regulatory guidance.

  • Responsibilities:Assure that microbiology testing for raw materials and finished product is completed to meet product manufacturing requirements for manufacture and release, including oversight of receipt of samples, testing, review and reporting of results
  • Schedule and coordinate product Sterility, Endotoxin and bioburden testing
  • Perform and or oversee endotoxin, sterility and bioburden method validations as well as other non-product related validations related to product testing and transfer. This includes authoring, executing and completing protocols as required
  • Coordinate the microbial identification program related to environmental and utility monitoring
  • Coordinate validations of equipment and instruments supporting Microbiology Laboratory Operations
  • Coordinate outsourced laboratory testing for raw materials and product
  • Provide training for employees on functions related to QC Microbiology such as Sterility, Endotoxin, and Bioburden Testing
  • Assure that laboratory procedures are current and update applicable procedures as required
  • Assure that all activities are documented, executed and in compliance with current Good Manufacturing Practices (cGMPs), Good Laboratory Practices (GLP), Good Documentation Practices and company policies
  • Other duties as assigned
    Qualifications:
    • BS in Microbiology
    • Minimum 6-8 years related experience in a Pharmaceutical/drug (FDA Regulated) industry preferred
    • Experience with sterility testing, endotoxin assays and validation, microbiological limits testing, knowledge of USP and EP/BP method/validation regulations, Microbiological identification method
    • Work under minimal supervision using Standard Operating Procedures and good judgment to effectively coordinate and execute assigned activities in support of production, Quality Control and Research & Development activities
    • Knowledge of cGMP and GLP, FDA/USP require Experience in a clean room environment required
    • Strong verbal, written and interpersonal communication with an emphasis on creating a motivated, effective working team
    • Strong organizational skills, the ability to prioritize work and manage multiple tasks independently
    • Demonstrated experience conducting investigations, writing protocols, SOP's, validating methods, staff training,
    • Strong computer skills and proficient at word processing and utilizing spreadsheets
    • Strong industry experience in pharmacopoeia testing, sterilization validation and general pharmaceutical microbiology
    • Knowledge of microbiology (industrial), environmental, and utility monitoring and aseptic processing

Keywords: ProStaff Solutions, Billerica , Sr Microbiologist, Other , Billerica, Massachusetts

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