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Quality Control Auditor Jobs
| Company | Catalent |
| Address | , Winchester, 40391 |
| Employment type | FULL_TIME |
| Salary | |
| Expires | 2023-11-23 |
| Posted at | 8 months ago |
Position Summary
QC Auditor is a professional career position for Quality Control Department. This position supports release of all materials from the quality control lab. Employees at this level can manage their time effectively and can function with minimal direction while executing a broad range of high visibility tasks to provide scheduling and alignment for the QC Department in support of internal and external customers. This position requires strong knowledge of technical and analytical requirements for the QC laboratory. QC Auditors are responsible for GMP and technical review of raw material/in process/finished good data for release. In addition, the responsibilities include supporting lab investigations, customer/agency audits and performing analytical testing as needed. 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.
First Shift: 6 AM-2:30 PM Monday-Friday
The Role
- Draft or review standard operating procedures as needed
- Other duties as assigned
- 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
- Assist in laboratory investigations
- Participate in customer/agency audits as necessary
- Perform analytical testing as needed
- Read and understand test methods from multiple compendia (i.e. USP/NF, EP, JP), internal Catalent methods, or customer/supplier methods+
- Assist in training QC Analysts
- Draft or review CAPAs and audit responses as needed
The Candidate
- Strong knowledge in Empower software
- Bachelor’s Degree (Preferred in Chemistry or equivalent)
- Work Experience – 3 to 5 Years in a Quality, Laboratory, Clinical or Chemical Manufacturing role (including internships or co-op experience)
- Ability to multi-task with high efficiency
- Ability to coordinate and prioritize to support manufacturing and quality agreements
Why You Should Join Catalent
- Tuition Reimbursement – Let us help you finish your degree or earn a new one!
- Several Employee Resource Groups focusing on D&I
- Employee Stock Purchase Program
- 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.
Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone’s safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.
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 [email protected]. 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 [email protected] for us to investigate with local authorities.
California Job Seekers can find our California Job Applicant Notice HERE.
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