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Quality Control Senior Associate
Job Description
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.
Responsibilities/Duties
Qualifications
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.
Responsibilities/Duties
- 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.
Qualifications
- High school/GED + 2 years work experience OR Associates and 6 months work experience OR Bachelors
- At least 3 years of industry experience within a GMP-regulated biotech or pharmaceutical environment
- Demonstrated 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.
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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!