Quality Assurance Associate, Auditing
About The Position
The Quality Assurance Associate, Auditing is responsible for performing desktop audits (questionnaires) and risk assessments for vendors supporting non-commercial and commercial products. The position also provides support for client audits and internal audits. This role is based 100% on-site at Catalent's Greenville, N.C. facility, which specializes in end-to-end turn-key solutions for oral solid dosage forms, including integrated formulation development, analytical services, commercial manufacturing, and packaging. The facility has seen over $100M of investments recently and features fit-for-scale capacity with potent handling capabilities, ideal for orphan or targeted drug development.
Requirements
- Bachelor’s degree with at least one year of professional experience in a regulated industry OR Associate degree with at least two years of professional experience in a regulated industry.
- Experience writing / revising GMP documents such as audit reports, procedures, protocols, investigations.
- In lieu of regulated industry experience, three years of experience in a role that requires evaluation, decision making against established procedures and technical writing.
Nice To Haves
- Experience supporting internal and / or external audits.
Responsibilities
- Plan, schedule and perform Vendor Desktop Audits (audit questionnaires), which involves the generation of Audit Report and Risk Assessment; track any CAPAs to completion and maintain the Approved Supplier List.
- Support the monitoring of performance and effectiveness of audit program.
- Ensure all work is performed and documented according to approved standard operating procedures (SOPs), in general compliance with cGMPs, and in a timely manner consistent with agreed upon schedules.
- Support site client audits, including on site and virtual audits, as necessary.
- Collaborate with Internal Lead Auditors in the scheduling and execution of internal systems audits, as necessary.
- Participate in process improvement projects and investigations.
- Review, redline, and update SOPs for GMP compliance.
- Other duties as assigned.
Benefits
- Medical benefits effective on your first day.
- Dental benefits effective on your first day.
- Vision benefits effective on your first day.
- 401K benefits effective on your first day.
- 152 hours of PTO.
- 8 Paid Holidays.
- Opportunity to work on Continuous Improvement Processes.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Number of Employees
5,001-10,000 employees
