QC Sr Analyst Flow Cytometry and Molecular

RoslinCT US•Hopkinton, MA

9h•$77,000 - $115,000•Onsite

About The Position

The Quality Control Sr. Analyst with a specialty in Flow Cytometry and Molecular assays will be executing analytical method transfer to Quality Control, optimize and troubleshoot assays for improvement. He/she will be responsible for authoring protocols, authoring Standard Operating Procedures (SOP’s) and Test Methods. He/she will be executing various quality control methods, analyzing and reporting data. He/she will assist in the implementation of new assay methodologies and the associated instrumentation and may support equipment onboarding activities. Identifies and supports initiation and completion of deviations, corrective and preventative actions, and laboratories investigation in compliance with all applicable quality systems and current cGMP’s. This position is highly visible in the organization and requires the ability to interface with multiple groups.

Requirements

Bachelor's degree in scientific discipline.
6+ years' experience in Quality Control manufacturing environment
Familiarity/experience in a cGMP QC laboratory is desirable
Ability to adhere to timelines for testing and reporting of data
Ability to function in a team-oriented environment
Excellent/Effective written and verbal communications skills
Adhere to scheduled timelines while maintaining flexibility and attention to detail
Ability to work in a fast-paced, collaborative environment and able to manage workload based on changing priorities
Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint).
Effective problem-solving capabilities.
Knowledge of analytical method lifecycle guidance (e.g., ICH)
Experience in cell-based assays, Flow Cytometry, ELISA, qPCR, dPCR

Nice To Haves

A highly organized work style that ensures timely execution of tasks.
A mindset that ensures accurate results.

Responsibilities

Conduct routine and non-routine analyses of samples for in-process, final product, and stability samples.
Execute sampling and QC sample management activities per procedure or written protocols.
Execute and support GMP cell culture and cell based assays for In-process, release, stability and method qualification activities.
Perform aseptic cell culture techniques, including cell thawing, expansion, Maintenance, counting, viability assessment, harvesting and preparation of cells for downstream testing.
Maintain cell lines ensuring appropriate documentation, traceability, storage and inventory controls, as needed.
Complete documentation for QC testing activities including data reports, reagent preparation, equipment logs and inventory logs.
Write/revise QC specific procedures and protocols.
Troubleshoot technical issues with Assays.
Train and mentor QC analyst on all the approved methods, GMP documentation and laboratory best practices.
Support implementation of information technologies that support documentation and data management systems.
Own investigations, change controls and CAPAs.
Other duties as assigned.