Quality Auditor

Position Summary:

Catalent is a global, high-growth, public company, and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee.

The Quality Auditor will be responsible for performing supplier audits regionally and in accordance with their assigned schedule in support of supplier integrity and oversight. The Quality Auditor will be performing audits, generation of audit reports and management of supplier CAPA to ensure required actions are completed within the required timeframe.

The Role:

• Responsible for organizing and performing the audits assigned and to develop a planned audit schedule to maximize audits conducted during one trip i.e., grouped audits based on location

• Work actively with the Catalent sites to manage and conduct Pre-Audit Preparation activities with an understanding of requesting sites risk assessment to ensure alignment to Global Standards

• Ensure generation of audit reports, management of supplier response and CAPA. Work collaboratively with the supplier to assess and conclude acceptance of supplier identified CAPA are completed in the required timelines

• Monitor and facilitate activities required to assure qualified status of existing and prospective suppliers in compliance with Global procedures and Regulatory requirements

• Generate Global Quality Agreements in accordance with templates and liaise with site and Suppliers to finalize to allow Supplier Quality Director approval

• Act as a liaison between suppliers and the quality teams globally during the management of supplier quality issues

• Lead and support Supplier issues / investigations affecting Catalent sites

• 50-60% travel expectations (domestic & international)

• Other duties as assigned

The Candidate:

• High School diploma, required - Bachelor’s degree, preferred; Certified auditor or lead auditor credentials, preferred

• 5+ years auditing experience

• Experience working in an auditing role within the Pharmaceutical/Medical Device industry, required

• Knowledge and understanding of the following principles and guidelines: EU EudraLex Volume 4 GMPs, 21 CFR Parts 111/210/211 (FDA), ISO, and related International Regulations affecting pharmaceutical products and medical devices

• Sterile/biologic/ATMP/C> auditing experience preferable

• Working knowledge of industry related guidelines such as ICH Q7, GHTF, and IPEC

• Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds

Why You Should Join Catalent:

• Several Employee Resource Groups focusing on D&I

• Potential for career growth within an expanding team

• Diverse, inclusive culture

• 152 hours of PTO + 8 Paid Holidays

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.

Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone’s safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers (https://careers.catalent.com/us/en) 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 (https://cdn.catalent.com/files/legal/CCPA-Privacy-Notice-at-Collection-for-California-Employees-and-Applicants-English.pdf) .