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RoslinCT · 21 hours ago

Sr. QC Analyst, Flow Cytometry and Molecular

Hopkinton, MA

Full-time

Onsite

Mid, Senior Level

$77K/yr - $115K/yr

4+ years exp

RoslinCT is a world-leading cell and gene therapy contract development and manufacturing organization creating cutting-edge therapies that change people’s lives. The Sr. QC Analyst will be responsible for executing analytical method transfers to Quality Control, optimizing and troubleshooting assays, and authoring protocols and SOPs while ensuring compliance with quality systems and cGMPs.

BiotechnologyClinical TrialsManufacturing

Hiring Manager

Stacy Adams Coburn

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

Flow CytometryCGMP Quality ControlAnalytical TechniquesQPCRSOP AuthoringTroubleshooting SkillsMS Office ProficiencyProblem-Solving SkillsCommunication SkillsTeam Collaboration

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