Quality Control Analyst I - Microbiology

Position Summary

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.

Work Schedule

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

Primary Responsibilities

• Conducts collection and testing of utilities such as USP water, clean steam, CDA and Nitrogen
• Performs Microbial Enumeration testing on final product release samples
• Isolates and sub-cultures microorganisms for identification
• Performs a variety of microbiologic assays such as sterility, growth promotion and other tests needed by the Quality Control group
• Maintains and monitors equipment and instrumentation used daily to ensure proper operation and calibration
• Writes and updates procedures, protocols, and logbooks
• Coordinates routine Environmental/Utility Monitoring, performs EM investigations, and clean room qualifications to support client campaigns

Candidate Requirements

• Bachelor’s Degree in a life science discipline or related
• Minimum of 1 year of experience in a cGMP regulated laboratory
• Familiarity with Good Manufacturing Practices (cGMP’s) and Aseptic Techniques
• Previous experience doing Environmental/Utility Monitoring, Bioburden testing and Microbial Enumeration (USP and USP) testing

Physical Requirements

• Sit, stand and walk on a regular basis, including gowning into ISO-8 production rooms

Pay

The anticipated salary range for this role in Massachusetts is $59,000.00 to $75,000.00 annually. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc.

About Catalent

• 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 + 8 paid holidays
• Generous 401K match
• Medical, dental and vision benefits
• Tuition Reimbursement - Let us help you finish your degree or start a new degree!

Equal Opportunity Employer

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

Important Security Notice

If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities.