Quality Assurance Auditor - Manufacturing

Regulatory Toolkit; Greenville (NC); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Paid holidays

Tuition reimbursement

Health benefits

Onsite wellness programs

Job summary

Catalent’s Greenville, North Carolina site is a major oral solid dose development and manufacturing campus. This Quality Assurance Auditor – Manufacturing role supports internal and external clients with routine and non-routine QA tasks on site.

Shift: Monday–Friday 8:00am–5:00pm, 100% Onsite in Greenville, NC. Responsibilities include data integrity, driving quality improvements, and ensuring compliance with SOPs and cGMPs across production and packaging operations.

Qualifications

• Bachelor’s degree with three years of pharmaceutical industry experience, including at least one year in QA.
• Associate degree with four years of pharmaceutical experience, including at least two years in QA.
• At least one year of batch record review and on-the-floor QA support.

Responsibilities

• Ensure data integrity through accurate transactions and documentation.
• Promote quality standards and a culture of quality and safety across the organization.
• Foster open communication within Quality Assurance and across the facility.
• Monitor and enforce compliance with SOPs, Quality Agreements, and applicable compendia.
• Perform in-process QA checks and review batch records.
• Release materials before manufacturing/packaging and provide real-time QA support.
• Ensure all work adheres to cGMP requirements.

Skills

Data integrity

Quality culture

Cross-team communication

SOP compliance

Batch record review

On-site operational support

Education

Bachelor’s degree + 3 years pharma

Associate degree + 4 years pharma

On-the-floor QA experience

Job description

Catalent’s Greenville, North Carolina site is a major oral solid dose development and manufacturing campus, delivering end‑to‑end, turnkey solutions from formulation development through commercial manufacturing and packaging. The site specializes in oral solid dosage forms, supported by integrated formulation expertise, comprehensive analytical services, and scalable manufacturing capabilities designed to support both commercial products and potent or targeted therapies, including orphan drugs. Backed by more than $100 million in recent investments, the Greenville operation features fit‑for‑scale infrastructure, potent handling capabilities, and a strong regulatory track record, making it a critical part of Catalent’s global network for advancing complex oral drug programs from development to market.

Position Summary

This Quality Assurance Auditor – Manufacturing role requires the ability to perform established routine and non-routine Quality Assurance tasks with minimal supervision in support of internal non-commercial clients, external clients and/or commercial processes and projects as assigned.

Shift: Monday- Friday 8:00am-5:00pm
Location: Greenville, NC
100% Onsite

The Role

• Ensure integrity of data through accurate transactions, documentation, and tracking of all cGMP activities
• Provide broad advocacy for the continued improvement of quality standards and the development and maintenance of a quality culture across the organization
• Work to create an environment of open communication, participation and information-sharing within and between teams within Quality Assurance and throughout the facility
• Support the development of a climate of quality and safety within the teams, by identifying and monitoring quality and safety standards
• Ensure compliance to all compendial, internal and client-specific requirements (i.e. SOPs, Quality Agreements, General and Informational Chapters in multiple compendia as applicable)
• Perform in-process QA checks
• Assure release of raw materials and components prior to manufacturing/packaging
• Provide real-time support activities for manufacturing and packaging operations
• Review batch records
• Ensure all work is performed and documented in accordance with approved standard operating procedures, in compliance with cGMPs
• Other duties as assigned

The Candidate

Minimum Requirements

• Bachelor’s degree with three years of experience in the pharmaceutical industry with at least one year in a direct Quality Assurance role; OR
• Associate degree with four years of experience in the pharmaceutical industry with at least two years in a direct Quality Assurance role; OR
• At least one year of batch record review and on the floor quality assurance manufacturing support

Why You Should Join Catalent

• Positive and fast-paced working environment focusing on continual improvement and innovation.
• Competitive Paid Time Off plus 8 paid holidays.
• Medical, dental, and vision benefits effective day one of employment.
• Tuition Reimbursement to help you finish your degree or earn a new one.
• Engaging site-based activities such as Music Bingo, Puppy Supply Donation Program, and seasonal events.
• Employee Resource Groups promoting Diversity and Inclusion.
• Green initiatives and community engagement programs including highway clean-up.
• Defined career path with annual performance reviews and growth opportunities.
• WellHub program promoting physical and mental wellness, including onsite fitness center.
• Exclusive discounts through Perkspot from over 900 merchants.

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.

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 [e-mail]. 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.

Massachusetts Lie Detector Test Notice:

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law may be subject to criminal penalties and civil liability. Consistent with Massachusetts law, Catalent does not require or administer lie detector tests as a condition of employment or continued employment.