Accentuate Staffing is partnering with a fantastic pharmaceutical company in Raleigh, NC who is hiring for a Quality Assurance Specialist. This is a six month contract opportunity with potential for hire, offering competitive pay while working onsite Monday through Friday from 8AM to 5PM. This person would be responsible for reviewing and approving documents and quality records in Veeva, as well as assisting with the implementation of corrective actions or process improvements. They would also be responsible for performing gap assessments of local documents against global documents and support the implementation of trackers for batch records, quality records, logbooks, maintenance records, and periodic reviews.
Responsibilities
- Perform document reviews and approvals for reformatted documents in Veeva as well as logbook reviews.
- Perform gap assessments of local documents against global documents.
- Review and approve maintenance records.
- Assist in data collection for periodic reviews.
- Review nonconformances, CAPAs and change controls.
- Review of systems release documentation (EM, water, nitrogen, processed compressed air, HVAC, WFI sanitization, CWOs, change controls, calibrations, and cleaning).
- Support implementation of trackers for batch records, quality records, logbooks, maintenance records, and periodic reviews.
Requirements
- Bachelors degree in science or engineering field OR equivalent experience.
- 2+ years of Quality Assurance is the minimum requirement.
- Must have 2+ year of QA experience in a pharmaceutical manufacturing environment.
- Experience with change management in a fast-moving, dynamic environment.
- Proficient in learning new systems and using Microsoft Office suites.
- Must have regulatory requirements understanding, specifically knowledge of FDA, OSHA, 21CFR Parts 210 and 211.
- Knowledge hands on experience with Veeva Vault is highly preferred.
