Microbiologist
- Perform microbiological testing on raw materials, finished products, in-process samples, and environmental samples.
- Conduct routine assays including sterility testing, endotoxin testing, microbial limits testing, bioburden, and growth promotion.
- Execute environmental monitoring (viable & non-viable) and personnel monitoring activities in controlled cleanroom environments.
- Interpret test results, analyze data, and document findings clearly and accurately per GDP requirements.
- Ensure full compliance with GMP, GLP, GDP, FDA, USP, and internal quality standards.
- Maintain, calibrate, and troubleshoot microbiology laboratory equipment (e.g., incubators, LAL systems, biological safety cabinets).
- Assist with development, qualification, and validation of microbiological testing methods and protocols.
- Participate in investigations related to OOS, OOT, deviations, and environmental excursions; support CAPA processes.
- Collaborate with R&D, Production, and Quality Assurance teams to support product development and regulatory compliance.
- Maintain accurate laboratory documentation and support internal/external audits as required.
- Stay current with advancements in microbiology, regulatory updates, and new testing technologies.
- Bachelor’s degree in Microbiology, Biology, or a related life science field.
- Minimum 1-3 years of experience in microbiological testing within a pharmaceutical or healthcare industry setting.
- Strong knowledge of microbiological testing methods and laboratory equipment.
- Experience with sterility testing, endotoxin testing, microbial enumeration, environmental monitoring, and personnel monitoring.
- Familiarity with GMP, GLP, FDA, USP, and regulatory quality standards.
- Excellent analytical, organizational, and problem-solving skills.
- Strong attention to detail and accuracy in laboratory practices.
- Ability to work independently and collaboratively in a fast-paced environment.
- Master’s degree in Microbiology or related field.
- Experience with advanced microbiological techniques such as PCR, ELISA, and microbial identification systems.
- Experience working in sterile injectable or aseptic manufacturing environments.
- Full-time onsite role in QC Microbiology laboratory and controlled cleanroom areas.
- Ability to stand for extended periods and perform repetitive laboratory tasks.
- May require lifting up to 25 lbs associated with laboratory materials or equipment.
- Requires proper PPE, including lab coats, gloves, safety glasses, and aseptic gowning when entering classified areas.
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