Microbiology Supervisor, Laboratory 3Rd Shift

Amerisourcebergen Corporation - Corporate Memphis , TN 38103

Posted 2 months ago

This position will report to the Quality Organization of PharMEDium. Supervisors at this facility will supervise staff, maintain sample schedules, and perform quantitative and qualitative analysis of our compounded admixed product for distribution to customers nationwide. The supervisor must be familiar with and knowledgeable of cGMP/GLP and 21 CFR Part 11 procedures.

  • Schedule samples for analysis

  • Support specialized projects

  • Organize the receiving, storing and logging in of samples from the clean room or inventory

  • Actively Participate in all regulatory inspections: FDA, DEA, Board of Pharmacy, and Internal Audits. Must have the ability and experience to draft submission ready responses to audit observations.

  • Review and approve data generated by biologists

  • Maintenance of Laboratory Notebooks

  • Review and initiate the revision of standard operating procedures

  • Active knowledge of current regulatory process and updates in the area of responsibility

  • Coordinate Instrument maintenance with Laboratory Metrology

  • Coordinate Method Transfers and Method Development

  • Write and execute protocols and reports

  • Understand OOS/Investigative reports

  • Develop Quality Reports

  • Mentor and Supervise Biologists and Technicians

  • Actively participle in New Initiative involving Lab topics

  • B.S. or Masters in Biology or related field with a minimum of 8 - 10 years of pharmaceutical laboratory experience or PhD with a minimum of 5 years of pharmaceutical laboratory experience and 0-2 years of supervisory experience of multiple staff members.

  • Must have environmental monitoring experience

  • Experience in FDA regulated industry.

  • Actively participated in audits (internal and regulatory) with independent close out of observations

  • Effective organization and planning skills

  • Excellent technical and verbal skills

  • Must have the ability to multi-task

  • Have problem solving skill set

  • Computer knowledge of data collection systems and or spreadsheet software, Microsoft Word, Excel, and PowerPoint

  • Understanding and experience utilizing the USP Compendia methods

  • Knowledge of Environmental Monitoring Programs

  • Advanced Knowledge and training of microbiology testing, GMP documentation of experiments, and Endotoxin Analysis.

  • Ability to travel up to 10%

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Microbiology Supervisor, Laboratory 3Rd Shift

Amerisourcebergen Corporation - Corporate