The Quality Assurance Manager reports directly to the Vice President of Quality. The Quality Assurance Manager is responsible for managing the quality systems within the company, contributing to the quality culture within the company and to approve or reject all products and documentation as it relates to CGMP.
Responsibilities include but are not limited to:
- Developing and implementing improvements to the Quality Management System
- Regular monitoring of the Quality performance indicators
- Training and continued development of staff
- Batch record review and release
- Auditing, internal and external
- Annual product review
- Root Cause investigation
- Communication to Customer and regulatory agency
Experience & Skills Required
- 5 to 10 years of experience in Pharmaceutical manufacturing of personal care, Medical Devices or OTC Drug products. Experience in Quality Management, labeling and regulatory with experience in regulatory submissions preferred.
- Computer; excel, word, SharePoint and capable of working in various databases
- Familiar with CGMP, ICH, FDA, OSHA industry guidelines
- The ideal candidate will be organized, a strong communicator, able to multitask, highly motivated, a team player, and will possess strong writing skills.