The Senior Analyst QC Microbiology is responsible for performing and overseeing the day to day operations in the QC Microbiology laboratory which include but not limited to Media Growth Promotion, Environmental Monitoring, Plate reading, Data review, and Investigations in support of GMP operations at the Cell Therapy Manufacturing facility (CTMF) in Takeda.
What You'll Do:
- This position will assist in site qualification, validation and commissioning activities where QC Microbiology knowledge and expertise is required, e.g. writing SOPs.
- This position will work closely with contract labs and vendors to address issues e.g. result turnaround times and sample submission discrepancies.
- Oversee day to day operations in the QC Microbiology laboratory
- Support site qualification/validation/commissioning activities as needed
- Qualified trainer in various Microbiological methods, and offer guidance to other analysts
- Draft and execute protocols as needed, and in support of site contamination control programs
- Work closely with contract labs to ensure that samples are submitted and tested in a timely manner
- Maintain a Microbial identification database for all in-house isolates recovered from the various monitoring programs
- Perform environmental monitoring of the manufacturing areas as needed
- Review routine environmental monitoring data and report excursions to management
- Support EM batch record issuance and review
- Initiate and investigate deviations and events in a Quality system, e.g. Trackwise
- Bachelor's Degree in Microbiology or related field
- Minimum of 5 years' experience in the biotechnology/pharmaceutical industry Minimum of 4 years' experience in a QC Microbiology laboratory in a GMP environment
- Ability to multi-task and adapt to changing priorities
- Knowledge and experience is Aseptic techniques, cleanroom behavior and Good Laboratory Practices (GLP)
- Experience in writing deviations/investigations in a quality system, e.g. Trackwise
- Experience in performing environmental monitoring in GMP cleanrooms
- Experience in cleanroom gowning
- General Microbiology knowledge and techniques
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations
Boston, MAWorker Type