Quality Control Senior Associate

This role is 100% on-site at the Holly Springs, NC facility, working a standard weekday schedule (8am–5pm) with some flexibility (start between 7–9am).

The ideal candidate will bring at least 3 year of industry experience within a GMP-regulated biotech or pharmaceutical environment. They must demonstrate strong knowledge of quality systems and QC laboratory operations with a proven ability to write, own, and drive closure of quality records, including deviations, CAPAs, and change controls.
This role requires excellent written communication, grammar, and investigative leadership skills. Candidates should be detail-oriented, proactive, and able to navigate shifting priorities in a fast-paced environment with minimal oversight. They will collaborate with multiple cross-functional teams and should be confident leading meetings and pushing investigations independently through to completion.

Experience with Veeva Quality Systems is highly desirable.

This position will be part of the Quality Control Deviation and Change Control team for start up and operations of the ANC facility.
Working collaboratively with Quality and Quality Assurance teams to author and own change control records and deviations in the DQMS Veeva System
Individual will lead investigation teams and help to collect and report metrics for the systems team
Individual may assist with review of validation documents to support equipment and computerized system onboarding.
Individual 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.