Product Quality Lead - Reagents

Job Title

Product Quality Lead - Reagents

Location(s)

Hopkinton

About Us

Revvity is a developer and provider of end-to-end solutions designed to help scientists, researchers, and clinicians solve the world's greatest health challenges. We pair the enthusiasm of an industry disruptor with the experience of a longtime leader. Our team of 11,000+ colleagues from around the globe are vital to our success and the reason we're able to push boundaries in pursuit of better human health.

Find your future at Revvity

Overview:

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.

Essential Duties and 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

Basic Qualifications:

* 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

Preferred Qualifications:

* 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)

Knowledge, Skills & Abilities Technical

Skills:

* 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

Leadership & Communication:

* 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

Physical Requirements:

* Ability to…