The QA Supervisor is responsible for the overall performance of QA group dealing with deviations, line inspections, change controls, complaints, SOPs, forms, and logbooks, etc. per cGMP and company standards. To supervise the QA group and all associated responsibilities in compliance with Renaissance procedures and good documentation practices. Support documentation during GMP audits. To review and approve all QA related documentation. To perform trending and report periodic quality metrics. To interact with internal and external clients in preparation for new products (development, clinical and commercial) manufactured at Renaissance. Carry out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
1. Daily management of activities related to line inspectors, deviations (batch records, specifications, QIS, etc.) 2. Reviews and approves deviations reports, change controls, product complaints, specifications, SOPs and forms. 3. Interact with other departments and customers to address investigations and customer questions. 4. Prepare monthly and quarterly quality metric presentations. 5. Review and approve cGMP documentation as related to functions of incoming QA and investigations. 6. Support documentation during client audits and regulatory inspections. 7. Lead and support process improvement teams within the company. 8. Utilize investigative techniques to determine root causes of deviations and to determine the proper corrective and preventive actions. 9. Responsible for all supervisory activities including, but not limited to, interviewing, hiring, training, coaching performance management, discipline, and termination recommendations. 10. Develop, motivate, and lead direct reports towards achieving organizational goals. Conduct periodic meetings and provide timely feedback. 11. Responsible for scheduling. Facilitates transitions between shifts and seamless handoffs. Communicates key information to peers, team members and production management. 12. Any other tasks assigned by management.
Bachelor's degree (BA or BS), preferably in a Natural Science.
A minimum of 3 years of relevant experience in the pharmaceutical industry in a Quality Systems or Quality Assurance environment.