Quality Assurance Auditor - Manufacturing

Catalent; Greenville (NC); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Medical/dental/vision plans

Tuition reimbursement

Paid time off

Wellness programs

Job summary

Catalent’s Greenville, North Carolina site is seeking a Quality Assurance Auditor – Manufacturing to perform routine and non-routine QA tasks in support of internal and external clients and commercial processes. The role emphasizes data integrity, cGMP compliance, and collaboration across Quality Assurance and manufacturing teams.

The position is on-site in Greenville, NC with standard Monday–Friday hours and duties including batch record review, material release, and real-time support for

Qualifications

• Proven ability to ensure data integrity and compliant documentation.
• Experience with cGMP, quality systems, and QA processes.
• Strong attention to detail and cross-functional collaboration.
• Experience reviewing batch records and supporting manufacturing QA activities.

Responsibilities

• Ensure data integrity and accurate documentation of all cGMP activities.
• Advocate for quality standards and maintain a quality culture across the organization.
• Foster open communication within QA and manufacturing teams.
• Support in-process QA checks and release of materials prior to production.
• Review batch records and ensure adherence to SOPs and client requirements.

Skills

Data integrity

Documentation accuracy

Quality mindset

cGMP knowledge

Collaboration

Education

Bachelor's degree in pharmaceutical sciences

Associate degree in a related field

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 3 years of professional experience in the pharmaceutical industry with 1 year in a direct QA role
• Associate degree with 4 years of professional experience in the pharmaceutical industry with 2 years in a direct QA role
• At least 1 year of batch record review and on the floor quality assurance manufacturing support
• Position requires the capacity to handle and manipulate objects using hands and arms

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 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.