Quality Control Microbiologist

Proclinical is seeking a Quality Control Microbiologist for a global pharmaceutical company located in Cambridge, MA.

The Analyst, Cell Therapies QC Microbiology is responsible for the performance of microbiological related activities at the Cell Therapies Manufacturing Facility. 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.

Must be eligible to work in the US.

Job Responsibilities:

• Perform environmental monitoring (viable particle monitoring -air, settle plates, contact plates as well as non-viable particulate monitoring) of the Cell Therapies Manufacturing Facility.
• 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.
• Perform gowning qualifications for personnel needing access to the internal GMP facility.
• Perform growth promotion tests.
• Assist in release testing (Sterility, Endotoxin and Mycoplasma) related to microbiology as needed to support the manufacturing of investigational new cell therapy drug products manufactured in the internal GMP facility,
• Assist in the EM investigations per SOP.

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
• Microbiology knowledge and practical experience of microbiology testing
• Excellent organizational, communication, and interpersonal skills
• Ability to adapt to changing priorities

If you are having difficulty in applying or if you have any questions, please contact Jackie Cerchio at +(1) 267-846-2026 or j.cerchio@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.

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