ClinLab Solutions Group · 2 days ago
Senior QC Analyst, Microbiology
Hopkinton, MA
Full-time
Onsite
Mid, Senior Level
$75K/yr - $100K/yr
4+ years expClinLab Solutions Group is seeking a Senior QC Analyst specializing in Microbiology to ensure adherence to regulatory requirements and client standards for cell therapy products. The role involves authoring and reviewing microbiology methods, supporting method lifecycle activities, and providing training for new methods.
BiotechnologyRecruitingStaffing Agency
Hiring Manager
Kaleigh Egan
Responsibilities
Author, review, approval, and final authorization of microbiology methods (test results and records, test methods, equipment records) and ensuring adherence to regulatory agency requirements, Client standards, policies, and SOPs for cell therapy products
Execute procedures for microbiology methods in support of method lifecycle activities including method transfer, qualification, validation, compendial verification, and performance monitoring
Support microbiology equipment installation and qualification, ensuring 21 CFR Part 11 compliance
Participate as microbiology subject matter expert (SME) in investigations, deviation, change controls, and CAPAs to support cGMP operations
Provide support to QC Operations as method SME: develop training approach, training documents and provide training for new methods
Perform non-routine/routine QC testing for in process samples, product testing, stability testing, or raw material testing as needed
Work collaboratively with cross functional departments including but not limited to QC Technical Services, Quality Assurance, and Program Management
Qualification
Required
Bachelor's degree in Biology (Microbiology)
4+ years of microbiology laboratory experience with rapid microbiological methods is a plus (rapid sterility, endotoxin, gram stain)
Experience in a cGMP QC laboratory environment performing environmental monitoring, contamination control and investigation writing
Excellent/Effective written and verbal communications skills
Escalate issues professionally and on a timely basis
Company
ClinLab Solutions Group
ClinLab Solutions Group is one of the only scientific resourcing firms that seamlessly supports the entire lifecycle — from early discovery through clinical development to commercialization.
201-500 employees
Funding
Current Stage
Growth StageLeadership Team
Steve Naclerio
Executive Vice President, Operations
Adam Katz
EVP of People & Development
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