Quality Control Microbiologist
1202- 1204 E D St Tacoma, WA 98421 US
The QC Microbiologist is responsible for quantitative and qualitative analysis of pharmaceutical manufacturing environments according to FDA, ISO, cGMP and Standard Operating Procedures. These areas include: Cleanroom, warehouse, drug product, drug substance, and FIO sampling. The Microbiologist will also be responsible for maintaining, updating and trending current procedures and data in accordance with local and international standards to support manufacturing, distribution and clinical trials. As part of the Quality Control department the microbiologist will also assist where needed during routine drug manufacture and release.
- Environmental monitoring of cleanroom areas including surfaces, air, water and personnel
- Routine testing in support of drug manufacturing and development
- Protocol and report generation/review for equipment validations/qualifications, and analytical method validations, which support QC activities
- Ordering / stocking of QC supplies
- Preparation of medias and reagents
- Compilation of Quality Control data for trending and evaluation
- Maintenance and update of Quality Control programs (e.g. Environmental Monitoring, Microbiome library) to meet or exceed regulatory requirements
- Revision and creation of GMP documents as needed
- Adherence and participation in Quality Systems (e.g., CAPA, Laboratory Investigations, Root Cause Analysis, etc.)
- Training of junior staff within the QC department
- Other responsibilities as assigned or needed
- Minimum of an Bachelor’s Degree preferred (B.S), in Microbiology, Biochemistry or closely related field with 3+ years prior laboratory experience, other degrees may be considered depending on work / education combinations.
- Vision corrected to 20/20 vision
- Lift minimum of 50lbs
- Minimum of 3+ years in a regulated GMP environment. Other regulated environments considered depending on experience (GxP).
- Previous validation experience with scientific equipment, analytical tests, and computer/equipment interfaces
- Familiarity with Electronic Documentation Systems (ERPs, ELN or similar) preferred
- Familiarity with data trending, for the use of alarm and alert levels, or out of trend (OOT) analysis.
Skills and Knowledge
- Proven work record of timely and efficient project completion
- Thorough knowledge and execution of Equipment, Process, and Analytical Validations
- Advanced knowledge of microbiological test methods, including isolation, identification, sequencing, storage, and propagation
- Thorough understanding of the creation and revision of GxP documents including but not limited to SOPs, Protocols, Analytical Methods, and Reports
- Working knowledge, interpretation, and implementation of regulatory standards (e.g. ISO, FDA, EU, etc.…)
- Excellent verbal and written communications
- Self motivated team player and can do attitude
- Supervisory experience a plus
Pay: $50,000 to 68,000. Salary will be commensurate with experience
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