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QC Analyst - 3rd shift
1100 Enterprise Drive Ford, KY 40391 US
Job Description
We are a growing Biotech Contract Development and Manufacturing Organization (CDMO) with an internationally recognized tradition of quality and service. We provide process development and GMP manufacturing services for Phase I/II clinical trials to industry leaders as well as innovative start-ups utilizing novel technologies to produce state-of-the-art vaccines and therapies for people when they are most in need.
This role is responsible for Environmental Monitoring sampling, analyzing, and aseptic monitoring and microbiological testing to support Phase I/II GMP manufacturing. Works in a fast-paced environmental supporting the quality control department of a CMO for manufacturing of biologic bulk drug substance, sterile finished drug product, and fill/finish.
Key Responsibilities include but are not limited to:
- Primary responsibility is in Environmental Monitoring in classified cleanrooms. Monitoring of surfaces, air, and non-viable air quality of ISO 5, 7, and 8 cleanrooms.
- Conducts testing of utilities such as USP water, clean steam, and testing of other manufacturing environments (air, surfaces)
- Builds credibility within the lab group by performing high quality work
- Works closely with manufacturing and QA to coordinate routine EM, changeover EM, and monitoring to support client campaigns
- Performs media fills and fill/finish monitoring which includes continuous monitoring of air quality, personnel aseptic technique, and environment integrity
- Acts as Quality Control authority for aseptic flow and behavior within cleanrooms
- Utilizes MODA to enter, compile, and trend environmental data for reporting purposes
- Works closely with Manufacturing and Quality Assurance staff to resolve quality issues with regard to the facility
- Effectively communicates results of own work through discussions and documentation with some input from supervisor
- Flexibility in following unique campaign requirements that may include off-hour and weekend work
- May conduct bioburden and membrane filtration testing on cleaning, in-process and release samples.
Experience & Education:
- Associates degree in a Life Sciences discipline and 2 years of relevant experience working in cGMP cleanrooms
- Experience working in cGMP Quality Control
- Experience with Microsoft Excel and Microsoft Word
- Strong attention to detail
- Familiarity with Good Manufacturing Practices (cGMPs)
- Have the knowledge and ability to apply basic scientific and regulatory principles utilized to solve operational, as well as routine quality tasks
- Must be able to work off hours or weekends as required
- LIMS or MODA experience a plus
- Experience conducting bioburden and membrane filtration testing a plus
Pay Rate Range: $20-27/hr depending on experience
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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