Thermo Fisher Scientific is looking for a Lead QA Technician for Batch Release to enable year-over-year double-digit growth by assisting through a vital role in manufacturing and across the supply chain.
Requirements
- 4+ years of manufacturing experience required
- Proficient with Microsoft Office Suite (Word, Excel)
- Prior experience in a quality assurance/document release work environment
- Prior quality management system experience
- Generating ERP System Reports
- ISO 13485 / CFR820 and Clean Room Manufacturing
- Lean 6 Sigma basics
Responsibilities
- Direct the daily workload to ensure batch review timelines are achieved while managing available resources and maintaining cGMP quality principles and standards including GDP and ALCOA
- Perform Batch Record/Document Review
- Review & Revise SOPs/Quality Documentation
- Assist/Drive the Tier process
- Work on Special Projects as assigned
Other
- Standard (Mon-Fri)
- Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
- Minimum Required Education: HS Diploma/ GED
- Advanced interpersonal skills
- Experience working in a team environment
