QA Operations Quality Specialist I
$26.39 - $39.59 per hourThermo Fisher Scientific
Quality Specialist I role focused on ensuring GMP compliance across manufacturing operations at a life-sciences company. The position involves documentation review, process monitoring, quality investigations, and collaboration with cross-functional teams in a regulated manufacturing environment.
Responsibilities
- Review and approve GMP documentation, batch records, and quality records
- Monitor manufacturing processes and maintain compliance with regulatory requirements
- Investigate quality events and drive corrective action implementation
- Support continuous improvement initiatives within manufacturing operations
- Conduct environmental monitoring and contamination control assessments
Requirements
- Bachelor's degree in Chemistry, Biology, Engineering, Life Sciences, or related field
- Minimum 1 year experience in GMP manufacturing environment
- Thorough knowledge of FDA, EMA, and international GMP regulations
- Proven ability to review and approve GMP documentation and batch records
- Strong understanding of quality management systems (CAPA, change control)
- Experience conducting quality investigations and root cause analysis
- Proficiency with quality systems software and Microsoft Office applications
Compensation: $26.39–$39.59 hourly; eligible for variable annual bonus
Vacancy posted 1 day ago
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