Quality Control Analyst - Microbiology

Work Schedule

Monday – Friday, 8:00am to 5:00pm. 100% on-site.

The Chelsea facility is Catalent’s global Center of Excellence for spray dry dispersion and Dry Powder Inhaler (DPI) capsule manufacture and packaging. The site features inhaled powder spray drying, as well as multiple commercial‑scale lines for capsule filling and blister packaging. On‑site spray dryers include best‑in‑class GEA Niro SD1, SD4 and SD7, the latter being the largest Good Manufacturing Practices (CGMP) unit of its kind for DPI in North America.

The Quality Control Analyst, Microbiology is responsible for Environmental/Utilities Monitoring and microbiological testing to support GMP manufacturing. They will conduct routine and non‑routine environmental/utilities monitoring and perform microbial testing of samples according to standard operating procedures. The Analyst compiles data for documentation of test procedures, participates in the preparation of investigations, summaries and reports, and reviews data obtained for compliance to specifications, reporting out‑of‑trend and/or out‑of‑specification results.

• Primary responsibility is Environmental Monitoring (EM) in classified clean rooms; monitoring surfaces, air, and non‑viable air quality of ISO 8 clean rooms.
• Collect and test utilities such as USP water, clean steam, CDA and Nitrogen; perform microbial enumeration testing on final product release samples; isolate and sub‑culture microorganisms for identification.
• Perform a variety of microbiologic assays such as sterility, growth promotion and other tests needed by the Quality Control group.
• Monitor equipment and instrumentation used daily to ensure proper operation and calibration.
• Assist in writing and updating procedures, protocols, and logbooks.
• Work closely with manufacturing and QA to coordinate routine EM, perform EM investigations, and conduct clean‑room qualifications to support client campaigns.
• Other duties as assigned.

• Bachelor’s Degree in a life science discipline or related field required.
• Minimum of 1 year of experience in a cGMP‑regulated laboratory required.
• Familiarity with Good Manufacturing Practices (cGMP’s) and aseptic techniques required.
• Previous experience in environmental/utility monitoring, bioburden testing and microbial enumeration (USP) preferred.
• Physical requirements:
  
  ability to sit, stand and walk regularly, including gowning into ISO‑8 production rooms.

The anticipated salary range for this role in Massachusetts is $59,000.00 to $75,000.00 annually. The final salary offered may vary based on experience, industry, skillset, education and business needs.

• Defined career path and annual performance review and feedback process.
• Diverse, inclusive culture.
• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives.
• 152 hours of PTO plus 8 paid holidays.
• Generous 401(k) match.
• Medical, dental and vision benefits.
• Tuition reimbursement to help complete or start a new degree.

Catalent is an Equal Opportunity Employer, including disability and veterans.