Principal Quality Associate, Client Audits

Catalent•Greenville, NC

5d•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 Principal Quality Associate, Client Audits will be required to perform and facilitate system-based audits and risk assessments for client audits, regulatory inspections and internal quality systems. The Principal Quality Associate, Client Audits will support non-commercial and commercial client audits and regulatory inspections.

Requirements

Requires a Bachelor’s degree with at least six years of Quality Assurance experience, five years of which must be in an auditing; OR an Associate degree with at least seven years of Quality Assurance experience, six years of which must be in an auditing role.
Experience with client and/or regulatory authority verbal and written interactions is a must.
Demonstrated knowledge of regulations and guidelines associated with cGMPs for pharmaceutical and biotechnology industries.
Knowledge of manufacturing and laboratory processes.

Nice To Haves

ASQ CQA certification preferred

Responsibilities

Plan, schedule, coordinate and conduct client audits; record findings to prepare responses.
Participate in Regulatory Inspections as required.
Assure the competence of client audit team members including subject matter experts, select appropriate audit support teams and assign roles and responsibilities, and train staff including subject matter experts to conduct or assist with audits.
Respond to questions and information requests from clients and regulatory authorities, complete questionnaires, track client quality agreement status and maintain audit program records.
Initiate CAPA in response to client and regulatory audit observations and conduct periodic follow-up with responsible parties; draft the overall audit response for review by management.
Act as a company auditing resources when required.
Monitor the performance and effectiveness of the quality support activities for client services.
Prepare reports on KPIs and CAPA status based on the overall achievements of the audit program.
Ensure compliance to all regulatory, compendial, internal and client-specific requirements.
Other duties as assigned.