Solstice Advanced Materials · 14 hours ago
Quality Engineer II
Baton Rouge, LA, United States
Full-time
Onsite
Entry, Mid Level
$76K/yr - $105K/yr
2+ years expSolstice Advanced Materials is a leading global specialty materials company that advances science for smarter outcomes. The Quality Engineer II will support the implementation and maintenance of robust cGMP Quality Systems, review and approve critical documentation, and collaborate with production and analytical teams to ensure product quality and compliance.
Electronics"Heating Ventilation and Air Conditioning (HVAC)"ManufacturingSemiconductor
No H1B
U.S. Citizen Only
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
Qualification
Required
Bachelor's degree in engineering or other science related discipline
Minimum of 2 years of experience in cGMP Quality Assurance role
Experience conducting and hosting cGMP compliance audits
Ability to work nights and weekends as needed
Due to compliance with U.S. export control laws and regulations, candidate must be a U.S. Person, which is defined as, a U.S. citizen, a U.S. permanent resident, or have protected status in the U.S. under asylum or refugee status or have the ability to obtain an export authorization
Preferred
Experience with practical application of FDA 21 CFR Part 211 and 21 CFR Part 11 in a chemical manufacturing plant
Familiarity with common chemical process unit operations
Experience with managing cGMP quality processes such as deviation investigation, CAPA, change control
Experience with design, execution and reporting of cGMP validation protocols
Company
Solstice Advanced Materials
Solstice Advanced Materials is a global leader in refrigerants, semiconductor materials, protective fibers, and healthcare packaging.
1001-5000 employees
Funding
Current Stage
Public CompanyTotal Funding
$1B2025-10-30IPO
2025-09-16Debt Financing· $1B
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