ClinLab Solutions Group · 1 week ago
Sr. QC Analyst, Flow Cytometry & Molecular
Hopkinton, MA
Full-time
Onsite
Mid, Senior Level
$75K/yr - $100K/yr
4+ years expClinLab Solutions Group is seeking a Sr. QC Analyst for their Flow Cytometry & Molecular Team. The role involves executing analytical method transfers, optimizing assays, and ensuring compliance with quality systems and cGMP regulations while interfacing with multiple groups in the organization.
BiotechnologyRecruitingStaffing Agency
Hiring Manager
Eric Johnson
Responsibilities
Perform routine and non-routine quality control testing on in-process samples and finished products
Operate and maintain laboratory equipment and instruments, ensuring proper calibration and adherence to cGMP Compliance
Provide support for method feasibility/transfers/qualification/validation and stability testing
Support analytical equipment installation and qualification
Apply technical knowledge and abilities to ensure all testing is performed in a compliant manner
Review all data in accordance with applicable procedures and cGMP requirements
Author, review, and/or approve Protocols, SOPs, Test Methods, and other procedures required to operate a QC laboratory
Participate in internal and external audits, inspections, investigations, change controls and CAPAs
Contribute to continuous improvement initiatives, identifying opportunities for efficiency gains and process optimization within the quality control function
Anticipate and troubleshoot problems. Communicate effectively with management regarding task completion, roadblocks, and needs
Become a qualified trainer on assigned assays and deliver training to analysts, documenting training per procedural and cGMP requirements
Provide support to QC Analytical Subject Matter Expert in Flow Cytometry
Work independently in a high-paced team environment, meet deadlines, and prioritize work from multiple projects
Communicate effectively with cross-functional peers, and department management
Qualification
Required
Bachelor's Degree in scientific discipline
4+ years of relevant experience in cGMP Quality Control Laboratory
Hands-on experience with various analytical techniques such as flow cytometry, qPCR, dPCR, ELISAs, cell-based assays, and scientific knowledge in the characterization and transfer of analytical methods
Knowledge of cGMP/ICH/FDA regulations
Ability to independently prioritize/manage activities
Ability to prioritize objectives from multiple projects and adhere to scheduled timelines while maintaining flexibility and attention to detail
Proficient in MS Office applications and information technologies that support documentation and data management systems
Strong troubleshooting, problem-solving skills, oral and written skills
Ability to multi-task and interact with multiple groups in a team-oriented environment
Preferred
Experience with rapid microbiological methods is a plus (e.g. mycoplasma)
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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