The Office of Quality Assurance (OQA) for RTI Health Solutions (RTI-HS) and Discovery Sciences (DS) is currently seeking Quality Assurance Lead Auditor conduct both virtual and in-person internal and supplier audits of US and European based sites to evaluate compliance with RTI and RTI-HS policies and procedures, applicable regulations, client contracts, and study protocols.
Reporting directly to the Vice President Quality Assurance and Regulatory Affairs, you will have strong experience as a lead Quality System Auditor in a Pharma, Medical Device, or Biotech setting or a combination experience performing audits in FDA regulated Good Clinical Practice (cGCP), Good Laboratory Practice (cGLP) or Good Manufacturing Practice (cGMP) organizations.
This role will allow for a flexible schedule, with some laboratory auditing activities requiring routine visits to our laboratories and office in RTP, NC. Additionally, you will be expected to travel up to 20%..
At RTI International, you will be provided the opportunity to conduct meaningful work in a collaborative, cross functional environment. We are focused on your career development and provide a generous benefits packages that includes tuition reimbursement, parental leave, paid time off, medical/dental, and 401K
Additional responsibilities will include but not be limited to:
- Independently responsible for the full audit process cycle from writing the audit plans, assembling an audit team, coordinating the conduct of the audit, hosting required audit related meetings, interviewing staff, and writing the audit report.
- Independently responsible for in-process, directed, and client required audits related to chemical synthesis and manufacturing as required by regulation (ex. 21 CFR 210/211) and/or client agreement.
- Conduct audits and inspections of GCP, GLP, GMP and client mandated records and documentation.
- Review and audit validated electronic and computer systems to meet internal, client, and regulatory requirements.
- Track and manage internal and external corrective and preventive actions.
- Maintain audit-related documents including annual schedules.
- Keep current on regulations and guidance.
- Track and review proposals with specific auditing requirements from sponsor or client.
- Bachelor’s level degree in a scientific discipline
- 5 years of experience working in a regulated research setting (cGMP, cGLP, cGCP, or equivalent non-interventional post market studies) required with preference given to candidates with QA experience in an FDA regulated setting.
- Demonstrated organizational and communication skills, both verbal and written
- Demonstrated knowledge of and experience with FDA and ICH GCP
- Proficiency in MS Office applications
- Ability and willingness to meet travel requirements up to 20%
- Ability to work both independently and as part of a team
- Ability to multi-task and adjust to changing work priorities
- 2 years of experience as a lead auditor strongly preferred.
- Lead QMS or other Quality Auditor Certification desirable
- Prior experience auditing validated computer systems and performing supplier audits