Quality Specialist

Addison Biological Laboratory is seeking a Quality Specialist to support Quality Control and Quality Assurance activities within our Companion Animal Division. This position is responsible for inspecting, testing, documenting, and evaluating materials and products to ensure compliance with cGMP requirements, FDA regulations, and company quality standards. The ideal candidate is detail-oriented, organized, and comfortable working in a regulated laboratory and manufacturing environment.

• Inspect, sample, test, and evaluate incoming materials, in-process materials, and finished products
• Review production, packaging, and labeling records for accuracy and compliance
• Support product release activities and maintain proper material status controls
• Manage stability and retention sample programs
• Coordinate and review contract laboratory testing
• Assist with investigations involving out-of-specification results, deviations, complaints, and quality events
• Monitor calibration, preventive maintenance, and environmental/storage conditions
• Generate Certificates of Analysis and maintain quality records
• Support SOP revisions, training activities, audits, and regulatory inspections
• Assist with Quality Assurance responsibilities as needed

• Bachelor's degree required; biology, microbiology, chemistry, or related science preferred
• 3–5 years of Quality Control experience in a cGMP-regulated environment preferred
• Working knowledge of laboratory testing, documentation practices, and cGMP requirements
• Strong attention to detail and problem-solving skills
• Excellent organizational and communication abilities
  
  Ability to work independently and as part of a team

• Regular standing and walking
• Ability to lift up to 25 lbs.
• Exposure to laboratory environments, chemicals, and humidity

Addison Biological Laboratory, Inc.
· Fayette, Missouri