Quality Assurance Associate, Auditing

Quality Assurance Associate, Auditing

Position Summary: 

• Work Schedule: Monday-Friday, Days

• 100% based on-site in Greenville, NC

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.

The Role:

• 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.

The Candidate:

• 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.

• Strongly prefer experience supporting internal and / or external audits.

• 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.

Why you should Join Catalent:

• Day one benefits! Medical, dental, vision and 401K benefits effective on your first day. 

• 152 hours of PTO + 8 Paid Holidays.

• Dynamic, fast-paced work environment.

• Opportunity to work on Continuous Improvement Processes.

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. 

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.