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Quality Specialist
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Addison Biological Laboratory, Inc.
Fayette, MO (In Person)
$52,500 Salary, Full-Time
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Job Description
Quality Specialist Addison Biological Laboratory, Inc. Fayette, MO Job Details Full-time $50,000 - $55,000 a year 3 days ago Qualifications General Contractor License Construction subcontractor management Construction safety management Bachelor's degree Construction Supervisor License Managing quality control inspection teams Stakeholder relationship building Full Job Description About the Role 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. Essential Responsibilities Quality Control Perform product testing, including purity, safety, and potency testing using ELISA and microbiological methods. Review and maintain production and quality control records. Prepare and submit required testing documentation. Assist with product release activities to support shipment of finished products. Quality Assurance Develop, review, and maintain Standard Operating Procedures (SOPs). Assist with investigations involving deviations and out-of-specification (OOS) results. Support corrective and preventive action (CAPA) activities. Coordinate laboratory equipment calibrations and review calibration records. Help maintain compliance with company quality systems. Regulatory Affairs Assist with maintaining compliance with USDA veterinary biologics regulations. Support annual reviews and updates of production documents, facility records, personnel files, and product labels. Participate in USDA inspections, internal audits, and regulatory reviews. Production & Product Development Assist with production of commercial pinkeye antigen. Support research and development projects. Perform general laboratory checks approximately one weekend per month (typically 15-30 minutes; paid for a full hour). General Responsibilities Maintain accurate records and documentation. Follow all safety procedures, company policies, and quality requirements. Maintain a clean and organized work environment. Collaborate with departments across the organization. Perform other duties as assigned. Qualifications Required Education Bachelor's degree in Biology, Chemistry, Microbiology, or a related life science field. Knowledge & Experience Laboratory experience. Experience with aseptic laboratory techniques. Understanding of good documentation practices and laboratory procedures. Proficiency with Microsoft Office Suite. Skills & Attributes Strong written and verbal communication skills. Excellent organizational and documentation abilities. Detail-oriented with strong analytical and problem-solving skills. Ability to manage multiple priorities and meet deadlines. Strong interpersonal and relationship-building skills. Team-oriented attitude and willingness to collaborate across departments. Physical Requirements Ability to lift and carry up to 30 pounds. Ability to sit, stand, walk, reach, stoop, kneel, and perform laboratory tasks throughout the workday. Ability to operate laboratory and office equipment. Ability to work in a laboratory environment with frequent interruptions and changing priorities.