Quality Assurance Associate, Auditing

Catalent•Greenville, NC

1d•Onsite

About The Position

Catalent’s Greenville, N.C. facility specializes in end-to-end turn-key solutions for oral solid dosage forms, including integrated formulation development, analytical services, commercial manufacturing, and packaging. This state-of-the-art facility has had over $100M of investments in recent years and features fit-for-scale capacity with potent handling capabilities, ideal for orphan or targeted drug development. The Quality Assurance Associate, Auditing is responsible to perform 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.

Requirements

Requires a 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.
Individual may be required to sit, stand, walk regularly and occasionally lift up to 15 pounds.

Nice To Haves

Strongly prefer 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.