Category: Scientific & Clinical
Job Title: Complaint Coordinator
Location: Yardley, PA
Start Date: Immediately
- Oversee call center regarding complaints including training, Q&A maintenance, and, in conjunction with Medical Affairs, relationship management
- Receive complaints from Call Center
- Coordinate complaint investigations with CMOs
- Review and approve complaint investigations/CAPA
- Reconcile complaints with Call Center and Medical Affairs (AEs)
- Escalate critical issues to management
- Maintain records of complaint investigations and related logs
- Perform trending
- Write reports
- Participate in Call Center Meetings
- BS minimum, with a minimum of 5 years of pharmaceutical quality experience.
- Possesses excellent written and verbal communication skills.
- Demonstrated experience managing complaints and related investigations
- Possesses thorough knowledge and understanding of pharmaceutical manufacturing and/or laboratory operations.
- Possess knowledge of FDA GMP (21CFR11) and Records (21CFR11) regulations.
- Proven ability to exercise judgment and determine appropriate action for technical problems of moderate scope and difficult complexity.
- Product release, audit, device, clinical or regulatory affairs experience a plus.
- Required travel up to 10%, primarily domestic.
Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.