Quality Assurance Associate

Holly Springs, MS - USA

Monthly Salary: Not Disclosed

Posted on: 2 hours ago

Vacancies: 1 Vacancy

Job Summary

Job Title: Quality Assurance Associate

Location: Holly Spring NC 27540

Duration- 6 Months

Start Date:2/23/2026to End Date: 08/22/2026 (Possible extension upto long term)

Job Description:
Reporting to the Batch Release Manager the QA Specialist supports review of batch documentation and release of internal and external commercial products while ensuring compliance with cGMPs site SOPs and regulatory requirements. Ability to prioritize record review and usage decisions to support business needs and communicating release needs throughout the organization.

Job Specific Responsibilities
1. Batch Release
1. Responsible for certification and/or rejection of incoming material and manufactured material in compliance with applicable licenses and legal requirements. Ensures compliance with regulatory requirements internal/external guidelines SOPs and specifications related to record review and product release. Ability to identify non-compliances impacting release and report/escalate as appropriate for resolution.
2. Supports the development and implementation of standard operating procedures (SOPs) and supplemental documents governing batch release activities. Authors reviews and QA approves Standard Operating Procedures (SOPs) protocols/reports work instructions etc.
3. Creates and maintains QA SAP Master Data builds in support of batch release.
4. Data population and approval of Lot Release Protocols. Supports Lot Release Protocol revisions and GLIMS data builds for LRPs.
5. Additional job responsibilities may be assigned.

Requirements:
Must have familiarity with SAP; strong preference for candidates who have used SAP for batch release in a prior role.
5 years related experience in Pharma Quality.
Strong organization administrative and data entry skills.

Preferred/Nice-To-Have:
Experience using Veeva and/or GLIMS

Job Title: Quality Assurance Associate Location: Holly Spring NC 27540 Duration- 6 Months Start Date:2/23/2026to End Date: 08/22/2026 (Possible extension upto long term) Job Description: Reporting to the Batch Release Manager the QA Specialist supports review of batch documentation and releas...