Location: Morrisville, NC
Position Type: Full-Time
Requirements
- B.A./B.S. or higher
- Previous experience as a GLP auditor in a regulated facility
- >2 years industry (pharmaceutical or CRO) experience, with knowledge and experience in a GLP environment
- Proven ability to manage multiple projects/tasks at one time
- Good time-management skills and demonstrated ability to provide deliverables within specified timelines
- Excellent written and oral communication skills
Responsibilities
- Monitoring studies and final reports, working with management and staff regarding compliance, training, hosting regulatory inspectors, and maintaining QA-related documents, specifically:
- Development and implementation of QAU procedures to ensure GLP compliance
- Training of personnel and QA staff
- Monitoring of facilities, personnel, methods, practices, records, and controls for GLP compliance
- Maintaining copies of protocols
- Conducting and documenting periodic internal audits and providing status reports
- Making recommendations for correcting deficiencies
- Documenting corrective actions taken
- Ensuring proper authorization and documentation for deviations for approved protocols or SOPs
- Reviewing final study reports
- Providing QA statement for study reports
- Maintaining master schedule and other QA-related documents
Additional Qualifications
- Experience with rodent studies and bioanalytical assays optional but desirable
- Desire to work in a responsive and fast-paced environment
- Detail-oriented individual with a dedication to quality
- Motivated self-starter with a strong work ethic
- Good communicator able to work with internal staff and external clients
Please Apply Below With
- Cover letter addressing individual qualifications based on requirements
- Resumé detailing education and work experience
- List of at least three references
