Quality Assurance Auditor - Analytical Review

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

Benefits offered by this job

Medical benefits

Dental & Vision benefits

Tuition reimbursement

Site activities

Job summary

Catalent Pharma Solutions in Greenville, NC seeks a Quality Assurance Auditor – Analytical Review to perform routine and non‑routine QA tasks with minimal supervision for internal and external clients and commercial processes. This 100% onsite role supports data integrity, cGMP compliance, and the ongoing development and manufacturing operations.

The successful candidate will review lab reports and COAs, stability reports in SLIM, and raw material releases in ERP, while promoting a culture of

Qualifications

• Bachelor’s degree in Life Sciences with at least 3 years in pharma QA and 1 year in QA role
• Associate degree in Life Sciences with at least 2 years in pharma QA and 2 years in QA role
• Demonstrated ability to review GMP documentation, laboratory data, batch records, reports, and quality records
• Ability to handle and manipulate objects using hands and arms

Responsibilities

• Ensure data integrity through accurate transactions, documentation, and tracking of all cGMP activities
• Advocate for quality standards and development of a quality culture
• Foster open communication within Quality Assurance and across the facility
• Identify and monitor quality and safety standards across teams
• Ensure compliance to SOPs, Quality Agreements, and compendial requirements
• Review/approve laboratory reports and COAs
• Review/approve stability reports (LWRs) in SLIM
• Release of Raw Materials in ERP System
• Ensure all work is performed per SOPs and cGMPs
• Provide real time support for laboratories
• Other duties as assigned

Skills

Quality Assurance

GMP

Documentation review

Data integrity

Education

Bachelor's degree in Life Sciences

Associate degree in Life Sciences

Tools

SLIM

ERP System

Job description

Job Description

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

We have an opportunity for a Quality Assurance Auditor – Analytical Review. This position requires the ability 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)
• Review/approve laboratory reports and COAs
• Review/approve stability reports (LWRs) in SLIM
• Release of Raw Materials in ERP System
• Ensure all work is performed and documented in accordance with approved standard operating procedures, in compliance with cGMPs
• Provide real time support for laboratories
• Other duties as assigned

The Candidate

• Bachelor’s degree in a Life Sciences discipline with at least 3 years of professional experience in the pharmaceutical industry and at least 1 year in a direct QA role
• Associate degree in a Life Sciences discipline with at least 2 years of professional experience in the pharmaceutical industry and at least 2 years in a direct QA role
• Demonstrated ability to perform detailed analytical review of GMP documentation, laboratory data, batch records, protocols, reports, and quality records
• 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 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.

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life‑cycle supply. With time‑tested experience in development sciences, delivery technologies, and multi‑modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life‑enhancing and life‑saving treatments for patients annually.