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Quality Control Senior Associate
Posted: 11/10/2025
2025-11-10
2025-12-13
Employment Type:
Contract
Job Category: Quality
Job Number: 4769
Job Description
This position will be part of the Quality Control Deviation and Change Control team for start up and operations of the NC facility.
Responsibilities:
Responsibilities:
- 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.
- Drive and manage all aspects of assigned deviation investigations from initiation to closure within QMS (Veeva), ensuring adherence to established timelines.
- Author well-documented and scientifically sound investigation reports that clearly explain the event, the impact, and the corrective actions.
- Conduct comprehensive root-cause analysis using standard industry tools (e.g., 5 Whys, 5M) to identify the root cause of quality events.
- Develop, implement, and track effective CAPAs to prevent the recurrence of similar deviations.
- Working collaboratively with Quality and Quality Assurance teams to author and own change control records
- Ensure all change control documentation, including justifications, impact assessments, qualification/validation requirements, and implementation plans are completed accurately.
- Manage change control records within QMS system (TrackWise or Veeva) and ensure timely review and closure.
- Effective and Efficient communication with internal and external parties.
- Excellent project management, organizational, communication, and problem-solving skills.
- High school/GED + 2 years work experience OR Associates and 6 months work experience OR Bachelors
- Deviation and Change control writing experience
- Veeva system experience
- Leadership capabilities - must be able to lead meetings, drive investigations.
- Hiring manager is focused on practical aptitude and writing skills.
- Strong writing and grammar skills.
- Collaborative and proactive.
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Ready to take the next step in your career? Explore job opportunities in the bustling area around Holly Springs, North Carolina, where growth awaits at every corner. Nestled in the heart of the Tar Heel State, Holly Springs offers a perfect blend of small-town charm and big-city amenities. From its vibrant arts scene at the Holly Springs Cultural Center to the mouthwatering Southern cuisine found at local favorites like the Mason Jar Tavern, this region has something for everyone. Boasting proximity to Raleigh, Durham, and Chapel Hill, as well as being a stone's throw away from attractions like the NC Museum of Art and PNC Arena, Holly Springs provides a unique and attractive environment for professionals looking to thrive. Dive into our job listings today and discover the endless opportunities this lively area has in store for you!