Product Quality Lead - Reagents

Revvity•Hopkinton, MA

5d•Onsite

About The Position

This position serves as the primary quality owner for reagent manufacturing lines, providing hands-on quality leadership and technical expertise. The role combines laboratory experience with manufacturing quality systems to ensure consistent product quality, regulatory compliance, and operational excellence across all reagent production activities. Key Focus Areas: Quality ownership of reagent manufacturing processes Technical leadership in laboratory and manufacturing environments Regulatory compliance management and oversight Cross-functional collaboration to maintain product standards Operational excellence across production activities Must be available for full-time on-site work at our Hopkinton location.

Requirements

Bachelor's degree in chemistry, biochemistry, biochemical Engineering or related scientific discipline AND 5+ years of hands-on laboratory experience with chemical or biochemical processes OR experience with batch record systems, documentation control, and manufacturing quality oversight
Experience with batch documentation systems, electronic batch records, and manufacturing execution systems
Proficiency with analytical chemistry, reagent formulation, and quality control testing
Knowledge of validation principles, cleaning validation, and equipment qualification
Experience with audit management and regulatory compliance programs
Understanding of GMP requirements for chemical and reagent manufacturing
Excellent written and verbal communication skills with strong attention to detail
Ability to lead manufacturing teams and drive quality culture
Strong problem-solving and root cause analysis capabilities
Project management skills with ability to support multiple manufacturing lines simultaneously
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

Nice To Haves

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)

Responsibilities

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, completeness, and GMP compliance (as applicable)
Create and update batch production records, work instructions, 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