Quality Control Microbiologist
Anika
8 days ago
On-site
Bedford, MA
$66,000 - $75,000 USD yearly
Operations
Responsibilities:
- Perform microbiological testing (bioburden, sterility, endotoxin, microbial identification, gram staining, bacteriostasis, growth promotion) for raw materials, in-process, bulk/finished products, and stability samples.
- Conduct purified water and DI water testing (bioburden, endotoxin, membrane filtration, TOC) per USP.
- Complete laboratory documentation and test records in compliance with SOPs, GMPs, and data integrity requirements.
- Support development, qualification, and validation of microbiological methods (e.g., new sterility/endotoxin methods).
- Author, execute, review, and approve validation protocols/reports for microbiological methods, autoclaves, depyrogenation ovens, and related systems.
- Collaborate with Engineering and R&D on process validation, equipment validation, and new product introduction.
- Review environmental monitoring results for classified cleanrooms; maintain databases and summarize for annual environmental reports.
- Support environmental monitoring programs; guide/training on environmental compliance.
- Verify technician testing; assist with onboarding/technical training.
- Maintain databases for microbiological testing/validation data.
- Participate in internal audits; support regulatory inspections and audit readiness.
- Perform other duties/projects as assigned.
Qualifications/Requirements:
- Bachelor’s degree in Microbiology, Biology, or related field (or equivalent experience).
- Minimum 1 year pharmaceutical/regulated experience performing microbiological testing.
- Hands-on experience with sterility, bioburden, endotoxin (LAL), microbial identification, gram staining, purified water testing, bacteriostasis, growth promotion.
- Validation experience (new product, microbiological method, and equipment).
- Knowledge of GMP, GLP, FDA regulations, and applicable ISO.
- Environmental monitoring experience in classified cleanrooms.
- Strong written/verbal communication; manage testing schedules and reporting deadlines; accurate documentation.
- Proficient with Microsoft Office (Word, Excel, PowerPoint).
Nice to Have:
- Aseptic processing/media fill experience.
- Autoclave and depyrogenation oven validation experience.
- Environmental monitoring trending database/annual report experience.
- Internal audit/regulatory inspection experience.
- Knowledge of USP microbiological testing and contamination control.
Benefits:
- Discretionary bonus; comprehensive healthcare benefits; HSA; 401(k) with up to 5% company match; employee stock purchase plan; accrued paid time off; additional long-term incentives incl. stock awards.
- Perform microbiological testing (bioburden, sterility, endotoxin, microbial identification, gram staining, bacteriostasis, growth promotion) for raw materials, in-process, bulk/finished products, and stability samples.
- Conduct purified water and DI water testing (bioburden, endotoxin, membrane filtration, TOC) per USP.
- Complete laboratory documentation and test records in compliance with SOPs, GMPs, and data integrity requirements.
- Support development, qualification, and validation of microbiological methods (e.g., new sterility/endotoxin methods).
- Author, execute, review, and approve validation protocols/reports for microbiological methods, autoclaves, depyrogenation ovens, and related systems.
- Collaborate with Engineering and R&D on process validation, equipment validation, and new product introduction.
- Review environmental monitoring results for classified cleanrooms; maintain databases and summarize for annual environmental reports.
- Support environmental monitoring programs; guide/training on environmental compliance.
- Verify technician testing; assist with onboarding/technical training.
- Maintain databases for microbiological testing/validation data.
- Participate in internal audits; support regulatory inspections and audit readiness.
- Perform other duties/projects as assigned.
Qualifications/Requirements:
- Bachelor’s degree in Microbiology, Biology, or related field (or equivalent experience).
- Minimum 1 year pharmaceutical/regulated experience performing microbiological testing.
- Hands-on experience with sterility, bioburden, endotoxin (LAL), microbial identification, gram staining, purified water testing, bacteriostasis, growth promotion.
- Validation experience (new product, microbiological method, and equipment).
- Knowledge of GMP, GLP, FDA regulations, and applicable ISO.
- Environmental monitoring experience in classified cleanrooms.
- Strong written/verbal communication; manage testing schedules and reporting deadlines; accurate documentation.
- Proficient with Microsoft Office (Word, Excel, PowerPoint).
Nice to Have:
- Aseptic processing/media fill experience.
- Autoclave and depyrogenation oven validation experience.
- Environmental monitoring trending database/annual report experience.
- Internal audit/regulatory inspection experience.
- Knowledge of USP microbiological testing and contamination control.
Benefits:
- Discretionary bonus; comprehensive healthcare benefits; HSA; 401(k) with up to 5% company match; employee stock purchase plan; accrued paid time off; additional long-term incentives incl. stock awards.