Job description
Position Scope:
The Senior Microbiologist is responsible for all microbiological testing of production materials; raw, in-process and finished goods; environmental monitoring under static and dynamic conditions and personnel monitoring under GMP conditions. Responsible for process and equipment validation (autoclave and depyrognenation oven) in cooperation with Engineering and R&D (New Product Sterility and LAL validation).
Specific Responsibilities- Development and validation of new or improved microbiological methods
- Perform bioburden, sterility and endotoxin testing of raw materials, in-process samples, bulk and finished products and stability samples
- Evaluating purified and deionized water for bioburden, endotoxin and TOC testing as per USP requirements
- Writing and/or approving validation protocols, coordinating and/or performing validation and writing and/or approving validation reports
- Establishing databases for microbiological and validation data
- Verify work of technicians and assists in training
- Review environmental condition of classified areas, maintain database for environmental results of clean room environment and summarize data for annual environmental report
- Report and investigate Out of Specification (OOS) results and Environmental Control Notifications (ECN)
- Investigate OOS results and ECNs; determine root cause, correct and implement corrective actions as appropriate
- Coordinate for the calibration of equipment used in the laboratory; investigate any impact from the discovery of Out of Tolerance (OOT) equipment used in the lab
- Ability to conduct various studies that support the validity of the QC Microbiology department including cleaning validations, disinfectant efficacy studies, residual disinfectant studies, growth promotion and media qualification
- Other duties and projects as assigned
Experience, Knowledge, and Skills Required- Requires BS in microbiology, biology or related science
- More than 5 years experience in pharmaceutical industry with microbiological testing such as sterility/bioburden, new product validation, LAL testing and validation, microbial identification, gram staining, purified water testing as per USP (membrane filtration, endotoxin and TOC), bacteriostasis and growth promotion assay
- Experience with GMP laboratory operations and FDA regulations
- Experience in environmental monitoring of clean room, aseptic media fill evaluation
- Excellent verbal and written communication skills
- Proven ability to meet deadlines for testing and reporting
- Proficient in the use of Microsoft Office Suite including PowerPoint
