Senior Advanced R&D Engineer/Scientist
About The Position
Advanced Materials is a global supplier of fluorine products, fine chemicals, additives, metals, films and fibers for products including pharmaceuticals, refrigeration, semiconductors and military protection. Advanced Materials is making the world safer, cleaner and enabling the modernization of a growing middle class by enhancing our customer offerings through a differentiated portfolio of chemistries, materials, value-added solutions and superior customer service. Our mission is to attract, retain and develop diverse and highly motivated, entrepreneurial employees striving to flawlessly deliver superior value to our customers every day. As a Quality Assurance expert for a new cGMP manufacturing team. Ensure that appropriate cGMP Quality Systems are in place through review and approval of procedures including master batch records, specifications and standard operating procedures impacting the safety, identity, strength, quality or purity of the cGMP products manufactured at the site. Conduct routine audits of 3rd party suppliers in support of GMP operations. Release or reject product based on detailed review of batch records and final product quality. Work closely with members of the production and analytical teams to expedite completion of quality system processes including deviation investigation, CAPA and change control management. Manage cGMP document control system and training program. Review production, analytical, and quality records yearly and generate an Annual Product Review report. Facilitate continuous improvement through regular review of procedures, internal audits, and preventative action implementation.
Responsibilities
- Manage the cGMP Quality System to meet requirements of FDA 21 CFR Part 211 and 21 CFR Part 11.
- Final responsibility and authority to approve or reject HON cGMP product
- Oversee activities concerning customer complaints and/or adverse events that include performing prompt investigations, instituting corrective actions where appropriate and identifying trends.
- Notify senior management of significant product quality issues and coordinate response
- Manage training matrix
- Interface with cGMP Customers and regulatory agencies as necessary
- Review, approve and uphold internal and external quality agreements
- Execute cGMP document control procedures
- Conduct and host internal and external cGMP quality system audits
- Coordinate quality system improvement projects
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
No Education Listed
