Quality Control Auditor
4 weeks ago
Position Summary
Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee. 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 material/in process/finished good data for release
Second Shift: Monday-Friday 7 AM-4 PM
Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee.
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 assigned
- Bachelor's Degree (Preferred in Chemistry or equivalent) Required.
- Work Experience - 3+ Years in a Quality, Laboratory, Clinical or Chemical Manufacturing role (including internships or co-op experience).
- General computer literacy including use of Microsoft Word and Excel.
- Safely perform testing required by position. Knowledge of and proper use of equipment. Safely handling chemicals and compounds.
- Regular cleaning of lab space as required. Assisting with other personnel with lifting of liquid containers and all objects of greater than 50 lbs.
- Maintaining clean environment for laboratory operations. Use of and safe handling of glass canisters, chemicals, and other required equipment.
- 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
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.
Important Security Notice to U.S. Job Seekers:
Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. 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.
California Job Seekers can find our California Job Applicant Notice HERE.
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