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Moderna · 17 hours ago

Specialist, Quality Control

Norwood, MA

Full-time

Onsite

Mid, Senior Level

$74K/yr - $118K/yr

5+ years exp

Moderna is a pioneering company revolutionizing medicine through mRNA technology. The Specialist, Quality Control role involves executing in-process and release testing for raw materials and drug products, ensuring compliance with cGMP standards, and contributing to continuous improvement initiatives within the QC Bioassay Lab.

BiotechnologyGeneticsHealth CareMedicalPharmaceuticalTherapeutics

Comp. & Benefits

No H1B

U.S. Citizen Only

Responsibilities

Execute in-process and release testing for raw materials, drug substances, and drug products in compliance with cGMP standards

Generate high-quality testing data for clinical studies and approved commercial products

Conduct technical assessments, manage deviations, and lead investigations impacting lab operations

Support method transfers and method qualifications in collaboration with development teams

Train colleagues through on-the-job (OJT) programs and act as a mentor to QC Bioassay staff

Represent the QC Bioassay team in the absence of management

Partner with QC leadership to ensure laboratory milestones and performance targets are met

Lead or organize continuous improvement initiatives and cross-functional projects

Troubleshoot assay performance, lab procedures, and equipment-related issues

Assist in scheduling, Tier meeting contributions, and QC resource coordination

Maintain and qualify laboratory equipment in line with validation standards

Write, revise, and maintain SOPs, technical protocols, and reports

Support audit preparation activities and regulatory compliance processes

Address CTU (Critical Temperature Unit) alarms and maintain system responsiveness

Follow all relevant GxP regulations, SOPs, and work instructions meticulously

Ensure adherence to Good Documentation Practices (GDP) and data integrity standards

Complete training and requalification assignments per defined due dates

Qualification

GxP regulationsMRNA technologyQPCR methodsSequencing methodsBS in BiochemistryMethod transfersMethod qualificationsContinuous improvementTeam collaborationMentoring

Required

Education: BS in a relevant scientific discipline (Biochemistry)

Experience: 5+ years of experience

Demonstrated aptitude or ability to learn: Able gain a strong understanding of GxP regulations (specify GMP, GLP, GCP, GVP or other applicable standards and guidance's

This position is site-based, requiring you to be at Moderna's site full-time. This position is not eligible for remote work

At Moderna, we are focused on delivering on our mission by enabling talent to thrive. For this role, we are currently unable to offer immigration sponsorship. Candidates must already hold work authorization in US and be able to maintain that status without the need for future sponsorship