Seeking a Quality Compliance Specialist for our client – a leading pharmaceutical and biotechnology CDMO. This is a great opportunity to contribute to the development and commercialization of innovative medicines, from early-stage development through final production.
Type: Direct Hire
- Compile data and generate Annual Product Reviews/Product Quality Reviews. Adhere to timelines outlined in pertinent standard operating procedures (SOPs) and communicate due date to respective departments and upper management. Provide the final report to clients.
- Plan, conduct and document internal audits. Evaluate and report findings.
- Plan, conduct and document external audits (Raw Materials, Contract Laboratory, Sterilization facilities, etc.). Evaluate and report findings.
- Assist with on-site cGMP audits performed by/for clients and potential clients. Represent Quality Systems and facilitate interactions between clients and personnel during the audit. Assist with management of observations and corrective actions in Trackwise.
- Manage and prepare client submission documents retrieved from supporting departments and assist in responding to deficiency letters.
- Represent Quality Compliance on client conference calls for submission readiness and support.
- Support upper management as necessary in preparation for, during and following regulatory agency inspections.
- Maintain knowledge of cGMP (US/EU) and company operating procedures and policies.
- BS degree in a science related field.
- 3+ years of related experience/training.
- Able to travel a minimum of 30%.