Quality Manager, Microbiology
Teva Pharmaceuticals
- Salt Lake City, UT
- Permanent
- Full-time
- Will oversee implementation of in-house microbiological testing including validation of methods, setting up the laboratory, scoping out equipment, etc.
- Will oversee implementation of appropriate clean-room environmental monitoring programs.
- Will oversee implementation and remediation of microbial risk assessments for the manufacturing facility.
- Tests finished product test samples or sends them out to contract laboratory for analysis. Oversees the work of junior microbiologist and reviews their test data and the quality of their data review.
- Prepares media used in the microbiological testing of drug products and components.
- Prepares samples for shipment to outside contract laboratory for microbiological testing.
- Performs advanced microbiological testing on drug products.
- Validates microbiology test methods.
- Reviews data generated by other Microbiologists and outside contract laboratories.
- Trains Junior Microbiologist on microbiology test methods.
- Drafts Standard Operating Procedures (SOP) for the microbiology laboratory.
- Prepares written reports of any investigations conducted.
- Ensures compliance with current Good Manufacturing Procedures (cGMP) requirements at all times.
5+ years of professional experience in a pharmaceutical microbiology laboratory; or an equivalent combination of training and experience.
Previous experience managing other junior microbiologists in a micro lab setting required.Skills/Knowledge/Abilities:
- Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), and other regulatory requirements.
- Microbiology and microbiological test method development and validation.
- Sampling methods, automated identification and quality control systems.
- Classical microbiology techniques (i.e. gram staining, pour and streak plating, culture maintenance, aseptic techniques).
- Microscope, autoclave, and laminar flow hood usage.
- Mathematics and statistics.
- Prefer management experience in a clean-room microbiology environment.
- Sample preparation techniques.
- Computer applications and programs.