QC Analyst II, Flow Cytometry & Molecular Biology

RoslinCT US•Hopkinton, MA

19d•$65,000 - $98,000

About The Position

The QC Analyst II, Flow Cytometry & Molecular Biology, executes analytical method transfers to Quality Control and optimizes and troubleshoots assays. The role authors protocols, standard operating procedures (SOPs), and test methods; performs quality control testing; analyzes and reports data; and supports implementation of new assay methodologies and associated instrumentation. The analyst also supports deviations, corrective and preventive actions (CAPAs), and laboratory investigations in compliance with applicable quality systems and current cGMPs. The position involves collaboration with multiple groups and requires independent work, assessment of method suitability, interpretation of results, and troubleshooting.

Requirements

Bachelor's degree in a scientific discipline.
3–5 years of relevant experience in a cGMP Quality Control Laboratory.
Hands-on experience with analytical techniques such as flow cytometry, qPCR, dPCR, ELISAs, and cell-based assays.
Scientific knowledge in characterization and transfer of analytical methods.
Knowledge of cGMP, ICH, and FDA regulations.
Ability to independently prioritize and manage activities.
Ability to prioritize objectives across multiple projects, adhere to scheduled timelines, and maintain flexibility and attention to detail.
Proficiency in MS Office applications and information technologies that support documentation and data management systems.
Strong troubleshooting and problem-solving skills, and strong oral and written communication skills.
Ability to multitask and interact with multiple groups in a team-oriented environment.

Nice To Haves

Experience with rapid microbiological methods, such as mycoplasma testing.

Responsibilities

Perform routine and non-routine quality control testing on in-process samples and finished products.
Operate and maintain laboratory equipment and instruments, including ensuring proper calibration and cGMP compliance.
Support method feasibility, transfers, qualification, validation, and stability testing.
Support analytical equipment installation and qualification.
Apply technical knowledge to ensure testing is performed compliantly.
Review data according to 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 and identify opportunities for efficiency gains and process optimization within quality control.
Anticipate and troubleshoot problems and communicate task completion, roadblocks, and needs to management.
Become a qualified trainer on assigned assays, deliver training to analysts, and document training according to procedural and cGMP requirements.
Provide support to the QC Analytical Subject Matter Expert in Flow Cytometry.
Work independently in a fast-paced team environment, meet deadlines, and prioritize work across multiple projects.
Communicate effectively with cross-functional peers and department management.
Execute analytical method transfers to Quality Control and optimize assays.
Analyze and report testing data.
Support the implementation of new assay methodologies and associated instrumentation.
Support initiation and completion of deviations, corrective and preventive actions, and laboratory investigations.