Sr. GCP Auditor
Deerfield or Home-Based ,
Sr. GCP Auditor
Summary of Responsibilities
With direction and oversight from the Program Manager, Director and executive levels and/or on behalf of customers the Sr.GCP Auditor plans and conducts external audits, anddelivers other quality services (gap assessments, inspection preparation, SOP writing/editing, QMS consulting) to our clients as assigned.The Sr. GCP Auditor will support others as a co-auditor and by reviewing/editing client deliverables such as audit plans and reports.The Sr. GCP Auditor may also be responsible for managing, directing, or mentoring Quality Services staff
As a member of the Quality Services department, the Sr. GCP Auditor is a model of regulatory and quality systems compliance and should function as a subject matter expert and advisor to his or her colleagues throughout the organization.
- Planning, conducting, reporting, and documenting GCP audits on behalf of clients either in a sole, lead, or co-auditor capacity
- Supporting other auditors and Quality Services staff by reviewing/editing client deliverables and internal documents
- Providing other quality services to clients as assigned
- Updating the Quality Services master and client specific trackers as assigned
- Maintaining GCP knowledge and expertise relevant to US regulated medical product life cycles
- Managing Quality Services staff, AC staff temporarily assigned to Quality Services projects or initiatives, and Quality Services associates/contractors
As needed and feasible (based on departmental workload), the Sr. GCP Auditor will perform or assist with any other tasks, programs, initiatives, or assessments as assigned by Quality Services management or executive.
The candidate must demonstrate excellent writing skills, be an effective communicator (including public speaking), have exceptional organizational skills, and be adept with applicable software systems. Travel up to 75% may be required.
- Education: Bachelor’s or equivalent degree in a relevant field of study (including but not limited to Quality, Business, Regulatory Affairs, Health Care, Research, etc.) is required. An advanced degree is preferred.
- Training: Current documented training in GCP; additional documented training in either GMP or GLP preferred.
- Certification: Has or will obtain within one year of hire at least one relevant certification (CQA, RQAP, RAC, etc.).
- Experience: At least five years of experience in the medical product development arena and a sound working knowledge of the pertinent U.S. regulations. He/she must have verifiable experience independently planning, conducting, and reporting quality assessments including audits.
This job description is a summary. It is not intended to be comprehensive in detail. Individuals with this job title will be expected to perform according to their individual goals and evaluations in addition to this job description and all applicable standards (SOPs, manuals, code of conduct, laws, regulations, etc.).