The Senior Quality Systems Specialist is a key member of the quality organization responsible for managing the customer quality complaint process including investigations, corrective actions, escalation to management and coordinating FDA Field Alert team meetings. Other functional responsibilities include authoring and revising quality system documentation, trending and evaluating product quality and performing internal audits of the quality management system.
- Manages product quality complaint investigations and associated CAPA(s).
- Evaluates product complaints for potential reportable events, and escalates to management as appropriate.
- Collaborates with Technical Support, Engineering, Analytical Laboratories, Manufacturing, Validation, Customer Service and Regulatory Affairs groups to ensure timely complaint investigations and closure.
- Facilitates third-party supplier and CMO investigations and requests for corrective actions.
- Presents at FDA Field Alert investigation meetings and quality councils.
- Performs routine trending of product complaints and evaluating trends, escalating issues as necessary.
- Additional tasks include: performing internal audits, providing support during external audits, reviewing documents for compliance with regulatory guidelines and applicable standard operating procedures, authoring document changes, managing change controls, and supporting quality metrics initiatives.\
- Bachelor of Science in a technical discipline or equivalent combination of education and experience.
- Seven (7) years of experience in quality and manufacturing in the pharmaceutical, medical device, or biological industries.
- Experienced in managing customer product quality complaints, effectively communicating in written form and collaborating with various internal and external business partners in problem resolution.