Quality Engineer II
About The Position
As a Quality Engineer II at Solstice Advanced Materials, you will be an integral member of a newly established cGMP manufacturing team for our Baton Rouge, LA facility, supporting the implementation and maintenance of robust cGMP Quality Systems. This role involves the review and approval of critical documentation—including master batch records, specifications, and standard operating procedures—that impact the safety, identity, strength, quality, and purity of cGMP products manufactured at the site. You will collaborate closely with production and analytical teams to facilitate timely completion of quality system activities such as deviation investigations, CAPAs, and change controls, while also overseeing the cGMP document control system and site training program.
Responsibilities
- Release or reject product based on detailed review of batch records and final product quality
- Manage the cGMP Quality System to meet requirements of FDA 21 CFR Part 211 and 21 CFR Part 11
- Approve or reject 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
