Quality Assurance Specialist
Rochester, MN (Required)
Reports to Director of Quality
Quality Assurance staff are responsible for oversight of quality and regulatory compliance for product manufacturing activities. Staff work to identify and reduce regulatory and compliance risk by continuous monitoring and evaluating facility policies and practices to ensure compliance is built into the operational systems. Quality Assurance staff communicate and work effectively with leadership to take necessary actions to mitigate identified risks.
Quality Assurance staff are accountable for the effective implementation of the Quality Management System (QMS) and serves as the subject matter expert on the policies, processes and procedures of the QMS by developing a broad knowledge of the practice, business and technology as it relates to product manufacturing.
- Develops and oversees the product manufacturing compliance program.
- Ensures clinical product manufacturing service risks are escalated to management.
- Maintains control and takes responsibility for third-party services providers (contract manufacturers, contract laboratories, etc.).
- Ensures compliance concerns are prioritized and resources identified.
- Performs review of product manufacturing documents for clarity and compliance.
- Works with manufacturing staff to ensure compliance with regulatory requirements associated with internal and external assessments and responses to citations.
- Develops regulatory and compliance training program for the intended audience. Maintains program and keeps it up to date.
- Receives, tracks and responds to customer and regulatory complaints.
- Leads the investigation of events that appear to be associated with regulatory violations. Works with relevant parties to resolve issue and take appropriate corrective and preventive action.
- A bachelor’s degree in a science-related field is required and a minimum of 2 years’ experience in a manufacturing quality control/quality assurance role.
Experience and Skill Requirements
- Knowledge and experience in FDA current Good Manufacturing Practices for product manufacturing is required. Additional experience with other requirements (Good Laboratory Practices, ISO, etc.) is highly desirable.
- Exceptional human relations and communication (written, verbal, and listening) skills are required. Should be very detail-oriented and have the ability to work independently and productively with minimal direction, and routinely exercise initiative and sound judgment.
- Strong analytic skills coupled with critical thinking skills are essential in this role. Must have demonstrated capacity to comprehend complex protocols, programs, and situations. The ability to exercise good judgment while under pressure and tight deadlines, and strong coping skills are required. Must be flexible in adapting to a variety of responsibilities, work assignments, and priorities.