QA Auditor – Analytical Review & Compliance

Catalent Pharma Solutions

Greenville (NC)

On-site

USD 65,000 - 90,000

Full time

3 days ago

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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