Quality Assurance Analyst (Biotechnology)
Quality Assurance staff are responsible for oversight of quality and regulatory compliance for analytic assay development and testing services. The staff works to identify and reduce regulatory and compliance risks by continuously 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.
Duties and responsibilities
- Develops and oversees the analytical systems compliance program.
- Provides knowledge and expertise to testing personnel on quality concepts and practices.
- Ensures analytical service risks are escalated to management.
- Maintains control and takes responsibility for third-party service providers (contract manufacturers, contract laboratories, etc.).
- Ensures compliance concerns are prioritized and resources identified.
- Performs review of analytical testing documents for clarity and compliance.
- Works with scientific 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.
Education and experience requirements
- 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.
Required skills and/or qualifications
- 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.
- Prolonged periods of standing at laboratory benches.
- Prolonged periods of sitting at a desk and working on a computer.
- Must be able to lift up to 15 pounds at times.