Quality Control Analyst I - Microbiology

Catalent; Chelsea (MA); On-site; USD 59,000 - 75,000; Full time

Benefits offered by this job

PTO 152 hours + 8 holidays

401K match

Medical, dental and vision benefits

Tuition reimbursement

Job summary

Catalent’s Chelsea, MA facility seeks a Quality Control Analyst, Microbiology to support GMP manufacturing through environmental/utilities monitoring and microbiological testing. Responsibilities include EM in ISO-8 cleanrooms, testing of USP water and nitrogen, and compiling data for investigations and reports.

The role requires a life science degree and at least 1 year in a cGMP lab, with preferred experience in bioburden and microbial enumeration.

Qualifications

• Bachelor's degree in life sciences required.
• Minimum of 1 year of experience in a cGMP regulated laboratory.
• Familiarity with cGMPs and aseptic techniques required.
• Experience in environmental/utilities monitoring and microbial testing preferred.

Responsibilities

• Perform environmental monitoring in ISO-8 cleanrooms, including surfaces and air.
• Collect and test utilities such as USP water, clean steam, CDA and nitrogen.
• Perform microbial enumeration testing on final product release samples.
• Support EM investigations and clean room qualifications.
• Assist in writing and updating procedures, protocols, and logbooks.
• Coordinate with manufacturing and QA to support client campaigns.

Skills

Environmental Monitoring

Microbiology

cGMP awareness

Aseptic Techniques

Bioburden testing

Microbial Enumeration

Documentation

Education

Bachelor's Degree in Life Science

Job description

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

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.

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 Role

• Primary responsibility is Environmental Monitoring (EM) in classified cleanrooms; Monitoring surfaces, air, and non-viable air quality of ISO 8 cleanrooms
• Conducts 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

The Candidate

• Bachelor's Degree in a life science discipline or related is required
• Must have minimum of 1 year of experience in a cGMP regulated laboratory
• Familiarity with Good Manufacturing Practices (cGMP's) and Aseptic Techniques is required
• Previous experience doing Environmental/Utility Monitoring, Bioburden testing and Microbial Enumeration (USP and USP) testing is preferred
• Physical requirements: This position requires you to 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. Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states.

Why you should join 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!

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