Quality Control Analyst I - Microbiology
About The Position
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 Quality Control 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 and reports out-of-trend and/or out-of-specification results. 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.
Requirements
- Bachelor’s Degree in a life science discipline or related is required
- Minimum of 1 year of experience in a cGMP regulated laboratory
- Familiarity with Good Manufacturing Practices (cGMP’s) and Aseptic Techniques is required
Nice To Haves
- Previous experience doing Environmental/Utility Monitoring, Bioburden testing and Microbial Enumeration (USP<61> and USP<62>) testing is preferred
Responsibilities
- Environmental Monitoring (EM) in classified cleanrooms
- Monitoring surfaces, air, and non-viable air quality of ISO 8 cleanrooms
- Collection and testing of utilities such as USP water, clean steam, CDA and Nitrogen
- Perform Microbial Enumeration testing on final product release samples
- Ability to isolate and sub-culture microorganisms for identification
- Performs a variety of microbiologic assays such as sterility, growth promotion and other tests needed by the Quality Control group
- Monitors equipment and instrumentation used daily to ensure proper operation and calibration
- Assists in the writing and updating of procedures, protocols, and logbooks
- Works closely with manufacturing and QA to coordinate routine EM, perform EM investigations, and clean room qualifications to support client campaigns
- Other duties as assigned
Benefits
- 152 hours of PTO + 8 paid holidays
- Generous 401K match
- Medical, dental and vision benefits
- Tuition Reimbursement
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
