QC Analyst

PRIMARY PURPOSE OF POSITION:

The QC Analyst, Microbiology, will provide support for manufacturing through environmental monitoring, water and steam testing. Prepare samples for outsourcing for routine and non-routine microbiology assays on raw materials, process intermediate, bulk and final product for release and stability. Responsibilities Include:

• Environmental monitoring for controlled areas and during aseptic fills
• Able to gown aseptically for work in clean room environments
• Preparation of samples for microbiological assays, such as endotoxin, bioburden, biological indicator and microbial identification
• Maintain in-house microorganisms for growth promotion and enumeration
• Utility sampling as required (water, nitrogen, compressed air, EM)
• Prepare new Microbiology lab for some micro testing
• Work on special projects (studies or validations) as assigned
• Ensure the laboratory equipment has been standardized, calibrated or monitored as appropriate for its application or function
• Should be a team player and also able to work independently
• Knowledge of cGMP/ICH Ph Eur. and FDA regulations
• Write up out-of-specification and out-of-trend reports and participate in laboratory investigation
• Initiate deviations and other associated documents when needed
• Review preliminary documentation
• Write, maintain SOPs/revisions
• Assist in trending water and EM for quarterly and annual review
• Other duties and responsibilities as assigned

MINIMUM QUALIFICATIONS:

Must be detail oriented and possess the ability to work within a teamwork environment. Requires strong communication skills. Proactive, creative, willing to learn quickly and well organized. Requires a B.S. Degree in Microbiology, or related field with 1 to 2+ years experience. This position requires good computer knowledge in the use of accounting software, Windows, Word for Windows, and Excel.

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