Quality Technician/Analyst - Microbiology Team

Job title: Quality Technician/Analyst - Microbiology Team

Position Summary Schedule and conduct Environmental Monitoring to support manufacturing activities and for product release while following GLP (Good Laboratory Practices), QO (Quality Organization) and Regulatory procedures. Preparation media for Quality Control testing to support manufacturing activities and for product release while following batch records, QO, and GLP procedures. Secondary responsibilities could require Perform routine glassware preparation, washing and sterilization in compliance with specified Standard Operating Procedures. Hours: 1st Shift. Overtime, weekends, and holidays may be required.

Position Responsibilities Under close supervision, the Laboratory Technician will perform routine laboratory procedures using aseptic technique, in compliance with specifications in all Standard Operating Procedures and Standard Test Procedures used to support testing and release of product.

• Prepare aseptic and non-aseptic media for other groups within QO.
• Perform Environmental Monitoring in production areas.
• Monitor processes and alert supervisory personnel of known or suspected quality problems.
• Practice basic aseptic laboratory procedures as per training and SOPs.
• Apply Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) to assigned work.
• Learn and demonstrate understanding of basic sterilization principles.
• Understand and use production schedules.
• Assist in inventory management of laboratory supplies etc. Maintaining testing reagents and supplies
• Understand and perform basic laboratory techniques/procedures as per training and SOPs.
• Review documentation for accuracy and completeness.
• Compile and report laboratory test results.
• Assist in Laboratory Investigations; Alert supervisory personnel of known or suspected quality problems.
• Contribute and participate in Continuous Improvement Projects (CIP)
• Understand company policies and procedures, i.e., Safety, SOP's, and cGMP's.
• Learn and comply with regulatory requirements such as USDA, FDA, EU
• Demonstrate ability to perform assigned work in a safe manner.
• Demonstrate ability to recognize potential safety hazards.
• Verify and validate data entry in Laboratory Information Management Systems
• Participate in trouble shooting and problem solving for routine tests and processes.
• Demonstrate technical awareness using data, good judgment, and experience.
• Communicate effectively between departments, shifts, and employees.
• Routine glassware preparation
• Washing of glassware
• Decontaminate materials from laboratories via autoclave sterilization.
• Sterilize glassware and other materials for use in laboratories.

Education and Experience Required:

• Associate's degree in biological sciences/chemistry
• One to two years relevant experience. Preferred:
• Bachelor's degree in biological sciences/chemistry
• Experience with aseptic manufacturing environments
• Competent using Window-based applications, specifically MODA, SAP, and Excel
• Experience working within regulatory requirement (USDA, FDA, EU, etc.)

Technical Skills and Competencies Required Required:

• Basic Aseptic technique, Excellent Organization, Verbal and Written Communication skills, Experience in media preparation and autoclave operation beneficial.
• Basic understanding of aseptic operation and microbiology. Preferred:
• Experience with aseptic practices and aseptic manufacturing areas, Knowledge of MODA SAP, LIMS, Process Runner, and Microsoft Excel.

Physical Position Requirements

• Ability to lift 20-50 pounds routinely.
• Withstand long periods of standing.
• Exposure to high temperatures (autoclaves).
• Manual dexterity using hands and fingers.
• Specific vision abilities required by this job include close vision work.
• Occasional need to sit, reach with hands and arms.
• Ability to work flexible hours, work weekend and overtime.