Quality Control Auditor
Position Summary
Monday-Friday 8 AM-5 PM
This position is 100% on-site in Winchester, Kentucky.
Catalent’s Winchester location is the flagship US manufacturing location for large scale oral dose forms, with integrated analytical and development services. With 28 years of expertise in product development, technology transfers and commercial manufacturing, and roots in industry-leading Glatt technology.
The Quality Control Auditor supports release of all materials from the quality control lab. The Quality Control Auditor is responsible for GMP and technical review of raw materials/in process/finished goods data for release.
The Role
Support release of raw materials, in-process, finished product by reviewing GMP documents (data, notebooks, certificate of analysis, validation/qualification reports, etc) for compliance to internal SOPs and approved test methods as well as technical accuracy
Read and understand test methods from multiple compendia (i.e. USP/NF, EP, JP), internal Catalent methods, or customer/supplier methods+
Participate in customer/agency audits as necessary
Assist in training QC Analysts
Perform analytical testing as needed
Assist in laboratory investigations
Draft or review standard operating procedures as needed
Draft or review CAPAs and audit responses as needed
Other duties as required in support of Catalent Pharma Solutions high performance
The Candidate
Bachelor’s degree in a scientific field (Chemistry or Biology preferred) with 2+ years of related experience required. Alternate degrees in a non-scientific field may be accepted with at least 3 years of relevant experience in a material testing laboratory.
Ability to work well under pressure and maintain efficiency both on an individual and team basis.
General computer literacy including use of Microsoft Word and Excel.
Previous analytical testing experience is preferred. Experience in the pharmaceutical industry preferred.
Proven ability to support multiple project initiatives or multiple projects (either in-process, finished products or raw materials) simultaneously while meeting customer deadlines and producing high quality work and documentation with minimal training, supervision and direction. Proven track record of success of obtaining high quality results with minimal error problem reports and a minimal amount of write-up corrections
Individual may be required to sit and stand for an extended period of time. Specific vision requirements include reading of written documents and frequent use of computer monitor and chemical testing materials.
Why You Should Join Catalent
Several Employee Resource Groups focusing on D&I
Tuition Reimbursement – Let us help you finish your degree or earn a new one!
Generous 401K match
152 hours accrued PTO + 8 paid holidays
Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.
personal initiative. dynamic pace. meaningful work.
Visit Catalent Careers to explore career opportunities.
Catalent is an Equal Opportunity Employer, including disability and veterans.
If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.
Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.
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