cGMP Batch Release Quality Specialist

Aegis Manufacturing & Engineering•Maryland Heights, MD

3d•$28 - $29•Onsite

About The Position

Join a fast-scaling manufacturer that supplies critical, healthcare-related products to hospitals and clinical partners nationwide. The site is GMP-driven, science-forward, and highly collaborative. This isn’t a massive, fully built-out corporate campus—success here comes from adaptability, teamwork, and hands-on problem solving in an evolving operation.

Requirements

Associate degree in Life Sciences or a related technical field (Bachelor’s preferred; relevant experience may substitute)
3+ years of QA experience in a GMP-regulated manufacturing environment
Hands-on background in batch record review, product release, and quality documentation/compliance
Proven in-process QA or manufacturing floor support
Proficiency with Microsoft Office and eQMS tools
Clear written and verbal communication; able to work independently while contributing to team goals
Capable of lifting up to 70 lbs; able to stand for extended periods, bend, kneel, and wear PPE

Nice To Haves

Pharmaceutical experience strongly preferred; backgrounds in biotech, medical device, food & beverage, chemical, or other regulated industries considered

Responsibilities

Execute QA activities: thorough document checks, batch record evaluations, and material/finished batch release
Ensure alignment with cGMP, FDA, ISO, and USP requirements
Deliver in-process QA support on the floor, including AQL inspections, line clearance verifications, and on-the-spot quality guidance
Review, disposition, and release raw materials, components, intermediates, and finished products via electronic quality systems
Reinforce GDP across all manufacturing records
Assist with investigations, root cause analysis, and CAPA implementation
Partner cross-functionally with manufacturing, operations, and QA to meet production timelines
Maintain training compliance and follow all safety and quality procedures
Support additional QA tasks as needed