Principal Quality Associate, Client Audits

Principal Quality Associate, Client Audits

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 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.

The Role:

• 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.

The Candidate:

• 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.
• ASQ CQA certification preferred
• Individual may be required to sit, stand, walk regularly and occasionally lift up to 15 pounds.
• Some exposure to hazardous chemicals and other active chemical ingredients.

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:

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