PharmEng Technology is currently seeking a Quality Assurance Associate in New Jersey. The position is available immediately conditional of a successful interview.
- Responsible for ensuring compliance with GVP, regulations and established procedures.
- Support the review of PV data (ICSRs, PSRs etc.)
- Utilize Quality Assurance databases and review documentation for compliance with GVP, FDA, ICH and other regulatory requirements and perform administrative tasks.
- B.Sc. degree in life sciences or related field and a minimum of 5 years of experience within the Biopharmaceutical Industry.
- Previous case processing experience required.
- Quality management experience required.
- International regulations knowledge required (ICH, CIOMS, EMEA and FDA).