
Senior Associate Quality Control
- Holly Springs, NC
- Permanent
- Full-time
The ideal candidate will have at least 1 year of experience working in a GMP-regulated lab or manufacturing setting, with a strong background in writing and owning quality records such as deviations, CAPAs, and changing controls. Experience using the Veeva Quality system is highly desirable. This individual must demonstrate strong communication and grammar skills, a working understanding of QC laboratory processes, and the ability to lead meetings and drive investigations independently. Candidates must be proactive, detail-oriented, and capable of contributing in a fast-paced environment with minimal oversight.Responsibilities:
- Working collaboratively with Quality and Quality Assurance teams to author and own change control records and deviations in the DQMS Veeva System
- Individuals will lead investigation teams and help to collect and report metrics for the systems team
- Individuals may assist with a review of validation documents to support equipment and computerized system onboarding.
- Individuals may author, revise and review documents and reports including but not limited to SOPs, test methods, safety assessments, trend reports, qualification/validation summary reports, technical reports.
- Support the startup of a GMP QC laboratory.
- Support routine activities over the weekends and public holidays as required.
- Deviation and Change control writing experience
- Veeva system experience
- Leadership capabilities - must be able to lead meetings, drive investigations.
- The hiring manager is focused on practical aptitude and writing skills. Strong writing and grammar skills.
- Collaborative and proactive.
#25-22038