All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.Overview
The Quality Compliance Specialist will support Quality Compliance objectives to ensure compliance to state, federal and other requirements. Responsibilities
- Plan, conduct and document internal audits. Evaluate findings and report these to the respective department and upper management. Assure implementation of any resulting corrective action plans. Use the internal audit program to assess the level of DPT's compliance with applicable cGMP, QSR and pertinent standard operating procedures (SOPs).
- Plan, conduct and document external audits (Raw Materials, Contract Laboratory, Sterilization facilities, etc.). Evaluate findings and report these to the respective companies and Renaissance management. Assure implementation of any resulting corrective action plans. Use the internal audit program to assess the level of Renaissance's compliance with applicable cGMP, QSR and pertinent standard operating procedures (SOPs).
- Assist with on-site cGMP audits performed by, or on behalf of, clients and potential clients. Represent Renaissance Quality Systems and facilitate interactions between clients and Renaissance 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 received from agency.
- Represent Lakewood 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.
- Performs other duties as assigned.
- Is able to travel a minimum of 30% (when travel restrictions are lifted)
Bachelor's Degree (BA or BS) required, a science related major preferred. A minimum of four years of related experience and/or training is required.
ASQ CQA & or RAC certification preferably