QC Microbiologist Analyst
About The Position
Johnson & Johnson is recruiting multiple QC Microbiologist Analysts for its MedTech operations in Gurabo, Puerto Rico. Reporting to the Quality Control leadership team, the analyst supports microbiological testing in Biosynthetic and Parenteral manufacturing operations. The role provides microbiological oversight and technical support to help ensure compliance with GMP requirements, regulatory standards, and company quality systems. It includes routine and non-routine testing, investigations, validations, environmental monitoring, and activities that support timely release of high-quality products. The position monitors Biosynthetic facility activities during third-shift operations and supports microbiological aspects of parenteral manufacturing, validations, and projects. The analyst also provides technical input on product quality during aseptic filling and media fills, supports equipment qualification and new technology introduction, and contributes to laboratory compliance, efficiency, and capacity projects. Work schedules may vary and can include second or third shifts, weekends, and holidays as needed.
Requirements
- A minimum of a bachelor's degree.
- Proven experience in Quality Control.
- Experience in a microbiology laboratory GMP environment.
- Background in aseptic processing.
- Knowledge of method validations and method transfers.
- Familiarity with U.S. and international GMPs and pharmaceutical regulations.
- Fluency in written and spoken Spanish and English.
- Availability to work third shift.
- Flexibility to work weekends and irregular hours.
Nice To Haves
- Degree concentration in Microbiology, Biology, Biotechnology, or a related Life Sciences discipline.
- At least six months of laboratory experience.
- Experience supporting parenteral operations.
- Experience with Microsoft Office (Word, Excel, PowerPoint) and laboratory data management systems such as eLIMS.
- Understanding of USP, EP, JP, FDA, and other international regulatory requirements.
Responsibilities
- Monitor Biosynthetic facility activities during third-shift operations, including viable, surface, and non-viable air sampling and water and compressed-gas monitoring and testing.
- Support microbiological aspects of parenteral manufacturing, validations, and projects.
- Conduct laboratory tests supporting parenteral production, including bacterial endotoxin tests, bioburden and in-process product tests, sterility tests, biological indicator testing, environmental monitoring of aseptic manufacturing areas, and isolate identification.
- Support equipment qualification activities and introduction of new technologies.
- Provide microbiological technical input on product quality during aseptic filling processes and media fills as needed.
- Support investigations and risk assessments when questionable microbiological results are generated, including aseptic processing investigations.
- Ensure compliance with quality control policies, procedures, and systems to support timely release of products.
- Develop and present metrics for manufacturing microbiological data evaluation and trending.
- Participate in internal and external cGMP audits.
- Support laboratory projects focused on compliance, cost reduction, operational efficiency, and increased capacity.
- Perform peer review of laboratory tests and environmental monitoring data.
- Support trending analyses, method validations and transfers, and special-study protocols and reports.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
