The W.S. Badger Company is seeking a Quality Systems Specialist. This fulltime role is responsible for ensuring that the Quality Management System meets Current Good Manufacturing Practices with the intention to improve the product quality and consistency. The Quality Systems Specialist project manages quality investigations, recommends corrective and preventative action plans, and facilitates change control. The Quality Systems Specialist will also serve as a key member of the FDA audit team and is responsible for creating quality improvement plans in response to FDA observations and cGMP consultant recommendations.
- Administer the change control system
- Author and revise procedures and work instructions
- Conduct OOS and nonconformance investigations and create CAPAs, as needed
- Contribute to the improvement of the Quality System by assessing trends in deviation management, complaints, and audit results, and helping to develop corrective actions
- Serve as member of the audit team during FDA inspections
Experience / Abilities Required:
- Excellent written communications skills and attention to detail are required
- Excellent organization and systems thinking
- 2+ years Quality Assurance experience working in a pharmaceutical manufacturing or packaging facility
- Experience with Microsoft Office programs required, and experience with QMS programs, and inventory control programs, preferred
Employee must be able to perform essential functions of the position with or without reasonable accommodations.