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 Renaissance'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 a any resulting corrective action plans.
Assist with on-site cGMP audits performed by, or on behalf of, clients and potential clients. Represent Renaissance Quality Systems and facilitate interactions between client and Renaissance personnel during the audit. Assist with the management of observations and corrective actions in Trackwise. Prepare or assist with responding to client observations in accordance with Renaissance SOPs.
Manage and prepare client submission documents retrieved from supporting departments.
Assist in responding to deficiency letters received from the agency.
Represent Quality Compliance on client conference calls for submission readiness and support.
Complete site reviews of compendia and guidance updates.
Prepare Annual Product Reviews or Product Quality Reviews for products produced at the Lakewood site.
Support upper management in preparation for, during, and following regulatory agency inspections.
Prepare and update drug listings for the Lakewood site.
Work with outside contracting site to maintain licenses/registrations within each state's requirements.
Prepare Annual Reports for each state as required and working with vendor for state licensing. Maintain vendor Licensing Database Tracking system.
Maintain and knowledge of cGMP (US/EU/Canada) and company operating procedures and policies.
Perform other duties as assigned.
Understand and comply with all Renaissance safety, environmental and quality practices and procedures as outlined in organizational/departmental guidelines and SOPs as well as applicable federal, state and local regulations.
Quality Compliance Sr. Specialist Qualifications
Bachelor's Degree (BA or BS) required. A minimum of six years of related experience and/or training is required.