Revvity
ProductQualityLeadReagents
“Product Quality Lead - Reagents at Revvity. Skills: Quality ownership of reagent manufacturing processes, Technical leadership in laboratory and manufacturing environments, Regulatory compliance management and oversight, GMP requirements, batch record reviews, CAPA investigations. Lead all quality aspects of assigned reagent manufacturing lines from start to finish. Monitor and approve critical quality parameters throughout production cycles”
What You'll Achieve.
ensure consistent product quality; regulatory compliance; operational excellence across all reagent production activities
Industry & Context.
problem-solving and root cause analysis capabilities
Must be available for full-time on-site work at our Hopkinton location., Ability to work in laboratory and manufacturing environments, Regular presence required in production areas for oversight and auditing activities, Lifting/carrying up to 25 pounds, Use of personal protective equipment as required, Potential exposure to chemicals and laboratory materials
What They're Looking For.
Must Have
Bachelor's degree in chemistry, biochemistry, biochemical Engineering or related scientific discipline, 5+ years of hands-on laboratory experience with chemical or biochemical processes OR experience with batch record systems, documentation control, and manufacturing quality oversight
Nice to Have
Advanced degree (MS/PhD) in Chemistry, Biochemistry, or Chemical Engineering, Pharmaceutical or biotechnology manufacturing experience with direct GMP compliance responsibility, Experience managing quality aspects of chemical manufacturing or reagent production lines, Background in protocol development, validation activities, and audit management, Six Sigma certification or equivalent process improvement training, ASQ certification (CQE, CQA, or similar)
What You'll Do.
Lead all quality aspects of assigned reagent manufacturing lines from start to finish
Monitor and approve critical quality parameters throughout production cycles
Develop and maintain comprehensive batch documentation systems for reagent manufacturing
Conduct thorough batch record reviews to ensure accuracy
and GMP compliance (as applicable)
Create and update batch production records
and quality control procedures
Establish documentation standards and train manufacturing personnel on proper record-keeping
Lead investigations of documentation discrepancies and implement corrective actions
Develop quality protocols and procedures specifically for GMP reagent manufacturing lines
Conduct regular audits of production laboratories supporting reagent manufacturing
Assess laboratory compliance with GMP requirements
data integrity standards
and quality procedures
Lead CAPA investigations for manufacturing deviations and quality issues
Support internal and external regulatory audits for reagent manufacturing areas
Collaborate with cross-functional teams on new product introductions and process improvements
Mentor manufacturing and laboratory personnel on GMP requirements and quality best practices
How You'll Work.
Team & Collaboration
Cross-functional collaboration to maintain product standards; Collaborate with cross-functional teams on new product introductions and process improvements
Communication Scope
Excellent written and verbal communication skills with attention to detail
Process & Methodology
Project management skills with ability to support multiple manufacturing lines simultaneously
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