Senior Auditor, Inspection
Premier Research helps highly innovative bio-pharmaceutical and medical device companies transform life-changing ideas into reality. We take on the most challenging areas of study, with a special focus on unmet needs in such areas as analgesia, CNS, rare diseases, medical device and diagnostics, and pediatric research. We’re looking for a talented and energetic
Senior Auditor, Inspection to join our team!
Working at Premier Research means being an individual - you will be recognized for what you do and you will truly have an impact. You will be working in a friendly environment with colleagues who are genuinely supportive regardless of location or seniority. Premier Research is on an exciting journey - there is a true buzz throughout the company, so come and be part of it!
- What You’ll Be Doing:
Promoting the Quality Ethos at Premier
- Acting as Point of Contact for Premier Research employees for input and guidance to ensure Sponsor,
- Site and Premier Research is appropriately prepared/competent to handle Regulatory Inspections.
- Continually improving the Inspection readiness Framework through active involvement with projects and incorporation of best practices and lessons learned.
- Driving the mitigation of complex business and/or regulatory gaps identified during the process of managing organization-wide inspection readiness activities.
- Collaborating with the Director, Global Quality systems and Director, Project Quality Systems to coordinate training sessions for Inspection readiness training and other GQS owned training activities
- Identifying solutions where process gaps and/or areas for improvement are necessary to assure compliance with GXPs, the study protocol and applicable regulations, as needed
- Ensuring compliance with established internal control procedures by examining records,reports, operating practices, and documentation
- Completing audit reports by documenting audit findings
- Communicating audit findings by preparing a final report; discuss findings with auditees
- Complying with federal, state, and local security legal requirements by studying existing and new security legislation, enforcing adherence to requirements, and advising management on needed actions
- Preparing special audit and control reports by collecting, analyzing, and summarizing operating information and trends
- Maintaining professional and technical knowledge by attending educational workshops, reviewing professional publications, establishing personal networks and participating in professional societies * Contributing to team effort by accomplishing related results as needed
- Ability to travel up to forty percent (40%) of time.
You'll Need This to be Considered:
- Bachelor’s degree, or international equivalent from an accredited institution, in Health or Life Sciences, or equivalent experience. BS/BA and specialized GxP experience in auditing (i.e. Sponsor, site, or vendor audits)
- Experience hosting Regulatory Inspections strongly preferred
- Ability to independently manage projects and conduct gap analyses
- Intermediate SharePoint (or equivalent document system) and Microsoft Office skills
- Demonstrated knowledge of ICH Guidelines, FDA Code of Federal Regulations and other applicable regulatory authority laws and regulations
- Experienced PC user proficient with Microsoft Word and familiar with MS Excel and MS PowerPoint
- Excellent oral and written communication of the English Language
- Excellent organizational, interpersonal and communication skills
- Excellent team player, collaborative, and effective within the quality team; able to build strong relationships across the organization