Lead Quality Assurance Specialist - Operations
Performs a wide variety of activities to ensure compliance with applicable regulatory requirements by conducting data and document reviews and analysis. Primarily responsible for QA oversight of the Acton facility. May conduct investigations related to manufactured product.
- Coordinates and assists with batch record review and data auditing for quality assurance, manufacturing support and product dispositions for products manufactured by our client.
- Primarily supports the Acton Manufacturing site. Assists with internal audits, upkeep of document Binder Sites, and record review for release of final product.
- Interfaces with Manufacturing, Technical Operations, Facilities and Quality Control.
- Coordinates, prepares and approves the process documentation for Product Change Over, QA release of raw materials and components, as well as the manufacturing of our clients products.
- Coordinates with Manufacturing to conduct QA Walkthroughs of Cleanrooms and Room Release Activities
- Conducts data and documentation reviews and analysis. Collaborates with other departments for investigations, EM alerts, change controls, deviations, and corrective resolution.
- Ensures Corrective Actions in Acton are implemented and assists in investigation of root cause.
- Works with Technical Operations to assist with QA compliance oversight for Acton validation, including Part 11 compliance.
- Keeps management team informed of the operations, progress and performance. Other duties as assigned.
- Requires a Bachelor’s degree with minimum of 7 years of related work experience
- Demonstrated knowledge of scientific principles.
- Has a minimum of 5 years’ experience with lot release functions and the ability to interface cross-functionally through auditing experience.
- Ability to work in a fast-paced setting, adjust to changing environment, setting priorities for self.
- Must be able to function independently with minimal direct supervision.