Piper Clinical Solutions is actively seeking a Sr. Quality Specialist to join a well-established Pharmaceutical Company in the Raleigh / Durham area.
Responsibilities for Senior Quality Assurance Specialist:
- Effectively review and approve CAPAs, investigations, bill of materials, and batch records in support of manufacturing processes and utilities.
- Serve as the main point of contact for third party vendors and project managers.
- Review and audit all documentation associated to manufacturing activities as well as lead and participate in internal audits.
- Conduct investigations for deviations on the manufacturing floor and research and development labs, conduct root cause analysis, and write Corrective and Preventative Action plans (CAPA).
- Work with a cross-functional team in a GMP environment including quality control, metrology, microbiology, and manufacturing.
Technical Requirements for Senior Quality Assurance Specialist:
- Bachelor’s Degree in Engineering, Life Science, or related field.
- At least 5 years of experience working in a GMP environment in a pharmaceutical or medical device manufacturing facility.
- Excellent written, verbal, communication, and organizational skills.
- Extensive knowledge of cGMP, FDA, and ICH regulations and guidelines.
- Hands on experience with batch records, quality systems, discrepancy management systems and deviation management systems.
Compensation & Benefits for Senior Quality Assurance Specialist:
- Compensation: $50,000-70,000 based on previous salary history and experience
- Full Benefits: Medical, Dental, Vision, etc
Qualified candidates please send resumes to Meg Smith at firstname.lastname@example.org
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