Senior Quality Assurance Investigator

Piper Companies is actively seeking a Senior Quality Assurance Investigator to join a biotechnology company conducting research in the field of gene therapies and genome editing, working on science that has never been done before. T he Senior Quality Assurance Investigator will be responsible for reviewing CAPA's, deviations, and change controls, driving all investigations to closure and resolution. This will be an onsite role located in the RTP area of North Carolina with hours from M-F 8:00-5:00 PM.

Responsibilities of the Senior Quality Assurance Investigator:

• Responsible for investigation & solution within GMP Manufacturing
• Own and support Quality events, including but not limited to, CAPA Change Control, deviations, effectiveness checks
• Work collaboratively with Quality partners to ensure investigations are closed and resolved
• Work directly with QAAP to provide better written deviations & investigations.
• Preform on the floor data gathering required for investigations, where gowning will be neccesary

Qualifications of the Senior Quality Assurance Investigator:

• BS, MS is a plus, in Quality, Life Sciences, or Engineering
• Minimum of 5-10 years of engineering experience with Quality Events writing/ compliance experience
• Experience with Gene Therapy or Cell Therapy
• Technical writing skills

Compensation of the Senior Quality Assurance Investigator:

• $55-$60/hr
• Medical, Dental, Vision, 401k, and PTO!

Key Words: Deviations, deviations writer, deviations investigator, GMP, pharmaceutical, improvement process, six sigma, investigations, engineering, science, computer science, quality, quality assurance, QA, Investigations, change control, CAPA, compliance, gene therapy, cell therapy

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