What are the responsibilities and job description for the cGMP Batch Release Quality Specialist position at Aegis Manufacturing & Engineering?
cGMP Batch Release Quality Specialist
Location: Maryland Heights, MO
Schedule: Monday–Friday, 8:00 AM – 4:30 PM
Pay: $28–29/hour (OT paid at 1.5x)
Job Type: 6-Month Contract-to-Hire
A Day in the Role
At 8:00 AM you’re on the floor, partnering with production to verify line clearances and perform Acceptance Quality Limit (AQL) inspections. As batches move, you provide real-time guidance to operators, ensuring cGMP expectations are met at every step. Late morning brings document checks and Good Documentation Practices (GDP) coaching. After lunch, you dive into batch documentation review and use the electronic quality system to disposition raw materials, components, intermediates, and finished goods. Throughout the day, you collaborate with operations and QA teammates, contribute to investigations and root cause analysis, and keep training records current. You wrap up by confirming release status and capturing any follow-ups for CAPA activity.
About the Company
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.
What You’ll Do
- 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
What You Bring
- 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
- Pharmaceutical experience strongly preferred; backgrounds in biotech, medical device, food & beverage, chemical, or other regulated industries considered
- Proficiency with Microsoft Office and eQMS tools
- Clear written and verbal communication; able to work independently while contributing to team goals
Working Conditions
- Operations occur in a regulated manufacturing setting with strict safety and quality controls
- Complete all required safety and compliance training
- Capable of lifting up to 70 lbs; able to stand for extended periods, bend, kneel, and wear PPE
- Occasional overtime and potential off-shift, weekend, or holiday coverage based on business needs
Why You’ll Like It Here
- Contract-to-hire with strong long-term potential
- Stable, well-funded organization with rapid site growth
- Hands-on QA visibility across manufacturing operations
- Direct, meaningful impact on product quality in a regulated industry
Salary : $28 - $29