Quality Control Specialist, QC Sample Management

4 weeks ago


Norwood MA, United States Randstad USA Full time

Quality Control Specialist, QC Sample Management Location: Norwood, Massachusetts (On-Site Manufacturing Campus) Shift Schedule: Wednesday - Saturday, 1st Shift (10-Hour Schedule) Compensation: $45.00/Hour Role Type: Contract with potential extension The Opportunity 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. Key Responsibilities: Here's What You'll Do 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. Oversee and coordinate the daily schedule to ensure timely sample processing, compliance documentation, and lab record completion. 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. Lead investigations and resolution of compliance issues related to sample handling. 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. Laboratory Maintenance Manage controlled temperature unit (CTU) systems, including maintenance and troubleshooting. Foster a robust culture of safety and compliance within the lab environment. Basic Qualifications (Here's What You'll Need) 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. Technical Skills: Detailed working knowledge of LIMS systems (e.g., LabVantage) and quality document systems (e.g., Veeva). Working knowledge of relevant and current FDA, EU, and ICH guidelines and regulations. Experience with gowning, aseptic technique, and general lab safety practices.



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