Quality Assurance Specialist- GMP Chemistry

Pay Rate Low: 65000 | Pay Rate High: 75000

Be the quality authority behind pharmaceutical manufacturing, using your chemistry or engineering expertise to drive cGMP compliance, lead validations, and shape quality systems in a growing organization where your impact is visible and valued.

Schedule: M-F 8a-5p

Job Type: Contract to Permanent

Location: St. Louis, MO

At this time, Astrix cannot transfer nor sponsor a work Visa for this position.

Relocation assistance is not available for this position.

Benefits Offered

• Medical/dental coverage!
• Weekly pay!
• 401k and PTO after 6 months!
• Great benefit package offered upon conversion!
  
  

Quality Assurance Specialist- GMP Chemistry Daily Tasks: What you will do:

• Lead and support Quality Assurance activities in a cGMP-regulated manufacturing environment, ensuring compliance with FDA and ICH quality requirements.
• Review, approve, and author quality documentation including SOPs, validation protocols, reports, and change controls to maintain internal and regulatory standards.
• Provide QA oversight for equipment, facility, computerized system, and process validation (IQ/OQ/PQ) in accordance with 21 CFR Part 11 and Annex 11.
• Conduct and support internal, external, and supplier audits, inspections, and risk assessments, ensuring timely corrective and preventive actions.
• Serve as a quality subject matter expert, collaborating cross-functionally to drive continuous improvement, data integrity, and consistent quality systems.
  
  

Quality Assurance Specialist- GMP Chemistry Qualifications/Requirements

• Bachelor’s degree in Chemistry, Chemical Engineering, or related scientific field.
• 5 years of QA experience in a cGMP-regulated manufacturing environment.
• Strong knowledge of cGMP, ICH Q7, and 21 CFR Part 11 requirements.
• Hands-on experience with validation/qualification (IQ/OQ/PQ) and audits.
• Ability to author and review quality documentation and work cross-functionally.
  
  

We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!

INDBH