Biological Technician (Wednesday – Saturday)

Location: Irvine CA

Shift: Wednesday - Saturday

Key Responsibilities

• Production & Laboratory Operations
• Manufacture biological indicator components in accordance with cGMP procedures including but not limited to:
• Spore seeding and inoculation
• Agar pour plate preparation and testing
• Harvesting and washing operations
• Preparation of subassemblies and raw materials
• Execute assigned production tasks in accordance with approved manufacturing procedures and schedules

Equipment Area and Material Support

• Perform routine preventative maintenance and basic troubleshooting of laboratory equipment per approved SOPs
• Conduct daily area housekeeping and maintain laboratory readiness in compliance with cGMP requirements
• Perform inventory reconciliation checks and restock laboratory supplies as required

Documentation & Compliance

• Prepare complete and review batch records and production documentation in accordance with cGDP requirements
• Accurately maintain charts inprocess records and inspection aids (IAs)
• Ensure personal compliance with all Federal State local and Company regulations policies and procedures

Operational Support & Communication

• Communicate operational issues risks or improvement opportunities to supervision or management
• Support test method development validation activities investigations or inspections as directed
• Collaborate with crossfunctional partners including Quality R&D Production Planning Manufacturing Engineering and Master Data as required

Education and Experience Requirements

• High School Diploma or GED required.
• Bachelors Degree in Biology Microbiology or a related scientific discipline preferred.
• 13 years of experience in a chemistry or biologics laboratory environment required.
• Experience working in an FDAregulated manufacturing environment preferred.
• Working knowledge of cGMP and cGDP requirements
• Basic laboratory techniques including aseptic processing
• Basic computer skills (word processing and spreadsheets)
• Ability to operate automated or semiautomated laboratory equipment
• Knowledge of SAP or inventory management systems preferred
• Ability to work in a manufacturing laboratory environment
• Ability to wear required personal protective equipment (lab coat gloves etc.)
• Ability to lift 3150 lbs

Schedule may include weekend work