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Quality Control Specialist, QC Sample Management
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Quality Control Specialist, QC Sample Management
Location: Norwood, Massachusetts (On-Site Manufacturing Campus)
Shift Schedule: Wednesday - Saturday, 1st Shift (10-Hour Schedule)
Role Type: Contract with potential extension
We are seeking a highly motivated and detail-oriented Quality Control Specialist to lead the growing QC Sample Management function.
This is a pivotal, high-impact role operating at the intersection of science, digital systems (like LIMS), and continuous improvement. You will serve as the Subject Matter Expert (SME) for cGMP sample lifecycle activities, leading a team of associates and ensuring timely, compliant sample coordination and testing across internal and external laboratories worldwide.
Team Leadership & Operations Management
Lead a team of QC Sample Management Associates supporting Chemistry, Microbiology, Bioassay, and Raw Materials workflows from CMOs and Development labs.
Create weekly schedules, lead team meetings, and manage hiring, onboarding, development, and performance reviews (including 1:1 coaching) for associates.
Maintain compliance of training records for the team.
Quality Systems & Digital Innovation
Act as the primary support for audit readiness and actively participate in internal and external inspections.
Author and revise SOPs, quality records, deviations, CAPAs, and change controls.
Partner with Digital teams to expand and optimize the use of our Laboratory Information Management System (LIMS, specifically LabVantage).
Contribute to the pathway for incorporating next-generation data tools, including Generative AI, into QC workflows to drive efficiency and data automation.
Manage controlled temperature unit (CTU) systems, including maintenance and troubleshooting.
BA/BS in a relevant scientific discipline with a minimum of 3-5 years of Quality Control experience in a cGMP organization, OR
MS in a relevant scientific discipline with a minimum of 1-3 years of Quality Control experience in a cGMP organization.
LabVantage) and quality document systems (e.g.,
