Lead QA Technician - 1st Shift
$25.6 - $34.13 per hourThermo Fisher Scientific Inc
Lead QA Technician role at Thermo Fisher Scientific overseeing pharmaceutical manufacturing quality and regulatory compliance. Responsible for GMP documentation review, batch record validation, and ensuring adherence to regulatory standards in a Rockville-based facility.
Responsibilities
- Review batch records for completeness of signatures, entries, and material reconciliation
- Approve and control labels, certificates of analysis, and certificates of compliance documentation
- Conduct critical reviews of GMP documentation and materials control
- Support regulatory inspections and customer audits
- Collaborate with pharmacists and cross-functional teams on quality protocols
Requirements
- 4 years experience in pharmaceutical quality assurance or GMP environment
- High school diploma or GED
- Advanced proficiency with quality documentation systems like TrackWise or Documentum
- Knowledge of root cause analysis and quality improvement methodologies
- Strong attention to detail with analytical problem-solving abilities
- Proficiency with Microsoft Office applications
Compensation: $25.60–$34.13 hourly
$25.6 - $34.13 per hour
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