Proclinical is seeking a Quality Control Analyst located in Cambridge, MA with a global pharmaceutical company.
- The Analyst, Cell Therapies QC Microbiology is responsible for the performance of microbiological related activities at the Cell Therapies Manufacturing Facility in Cambridge.
- This position is responsible to assist in all microbiological related activities needed in the in-house GMP cell therapies production of investigational new drugs from development, transfer, (re-)qualification, (re-)validation to routine performance activities.
- Perform environmental monitoring (viable particle monitoring -air, settle plates, contact plates as well as non-viable particulate monitoring) of the Cell Therapies Manufacturing Facility in Cambridge.
- Perform plate reading and Data entry/verification of the test results.
- Perform RODI sampling.
- Responsible for shipping and tracking samples and test results.
- Participate in environmental monitoring performance (re-)qualifications and aseptic process (re-)validations.
- Maintain data integrity and ensure compliance with company SOPs, specifications, and cGMP regulations.
- Keep the Microbiology lab clean, safe, and tidy all the time.
Skills and Requirements:
- Bachelor's Degree in Microbiology or another relevant field
- Minimum of 0-1 years' experience in the bio/pharmaceutical industry
- Minimum of 0-1 years' experience in GMP QC Microbiology laboratory
- Experience in performing environmental monitoring in GMP cleanrooms (Grade A-C)
- Experience in gowning qualification and aseptic techniques
If you are having difficulty in applying or if you have any questions, please contact Kate Heffernan at (+1) 610-624-3327 or K.Heffernan@proclinical.com.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.
Proclinical Staffing is an equal opportunity employer.