Senior QC Analyst, Flow Cytometry & Molecular

RoslinCT; Hopkinton (MA); On-site; USD 90,000 - 140,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) program

Educational assistance

Job summary

RoslinCT is seeking a Quality Control Senior Analyst with a specialty in Flow Cytometry and Molecular assays in Hopkinton, MA. The role focuses on analytical method transfer, optimization, troubleshooting, and data reporting within a cGMP QC environment.

Ideal candidates have 6+ years in QC manufacturing, experience with cell-based assays, and strong documentation, communication, and teamwork skills. Weekend/holiday coverage and potential shift flexibility are required.

Qualifications

• Bachelor's degree in a 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
• Weekend and Holidays, are required. Flexible shift work may be required on occasion in support of 24/7 manufacturing operations.
• Job will require ability to lift up to 25 pounds, stand for extended periods of time, and complete repetitive tasks.

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.
• Knowledge of analytical method lifecycle guidance (e.g., ICH).
• Experience in cell-based assays, Flow Cytometry, ELISA, qPCR, dPCR.
• 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.

Skills

Organized work style

Attention to accuracy

MS Office proficiency

Problem solving

Communication skills

Education

Bachelor's degree in scientific discipline

Job description

RoslinCT is seeking a Quality Control Senior Analyst with a specialty in Flow Cytometry and Molecular assays in Hopkinton, MA. The role focuses on analytical method transfer, optimization, troubleshooting, and data reporting within a cGMP QC environment.

Ideal candidates have 6+ years in QC manufacturing, experience with cell-based assays, and strong documentation, communication, and teamwork skills. Weekend/holiday coverage and potential shift flexibility are required.