Senior QC Laboratory Specialist
$58,635–$75,899 year
On-siteQuality, Georgia, United States
Job Summary
Conduct product and raw material testing, prepare reagents, and troubleshoot calibrated equipment in an aseptic environment. Investigate failures, execute validation protocols, and complete Out of Specification, Non-conformance, and Incoming Rejection forms. Write and revise standard operating procedures, develop chemical testing procedures, and coordinate failure investigations using lab-scale simulations. Assist in writing validation reports, make recommendations on test methods, and train laboratory technicians. Maintain lab supplies and order necessary materials. Work the 1st shift (6am - 2:30pm) with overtime as needed. This role supports quality assurance at STERIS's Aseptic Manufacturing Facility in St. Louis, MO, ensuring adherence to ISO, FDA, and EU regulatory standards.
Required Qualifications
- Bachelor's Degree
- 4 years of relevant lab testing experience in a regulated industry (IE: FDA/ISO13485)
- Knowledge of standard quality tools such as FMEA (Failure Modes Effect Analysis), Root Cause Analysis and statistics
- Ability to work in aseptic environment and meet gowning requirements
- Ability to wear necessary Protective Equipment (PPE)
- Ability to operate independently and resolve problems of low to moderate complexity, including moderate impact decisions
- Ability to initiate action to achieve project goals
- Lifting, Pushing, Pulling between 10 - 25 lbs
- Bending, walking, standing, sitting, visual acuity, needed
Desired Qualifications
- Bachelor's degree in biology, microbiology, or other related degrees
- Experience working in aseptic manufacturing (food, chemical, pharmaceutical etc.) environment
- Gowning and/or clean room experience
- Experience administering gowning assessments for other employees
- Strong verbal and written communication across departments, especially operations
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