Location: Berwyn, PA
Are you passionate about the life sciences and would love to be part of advancing medicine in the neurosciences? You will have the opportunity to work alongside energetic and passionate people that believe in collaboration and open feedback. A casual culture, with serious and ambitious goals. If you are a seasoned GCP Auditor, This may be for you!
Some things you will do in the role include:
- Plan and conduct assigned audits
- Perform for cause audits as needed
- Write and issue audit reports, ensuring clear communication of audit findings to auditees and management
- Review responses to audit findings for appropriateness and completeness
- Close assigned audits
- Develop CAPAs as appropriate.
- Prepare for and host/support Regulatory Authority Inspections
- Write/review/revise QA SOP/WI
- Provide guidance to staff/management on quality related matters
- Contribute to creation of company QMS
Some things you will bring to the role:
- Bachelor’s degree in life science, healthrelated or pharmaceutical field with advanced degrees in life science preferred but not required.
- CNS experience highly preferred
- At least 10 years relevant experience in Pharmaceutical, Biotech and/or CRO environment
- Previous experience in the conduct of multiple audit types (vendors, investigator sites, trial master files, data management and safety reporting) is essential
- In depth knowledge of GCP requirements
For immediate consideration, email email@example.com and mention Job#17624