QC Analytical Lab Technician

Work location: Devens, MA • Duration: 6 months • Pay rate: $40.00–$45.50/hr on W2 • 100% on-site

Skills

• Pipetting technique
• Analytical chemical bench testing (assay execution)
• cGMP knowledge
• 1–2 years industry experience

About the role

The QC Analytical Lab Technician supports Quality Control bioanalytical testing for method validation, critical reagent qualification, in-process, release, and stability testing of clinical and commercial cell-therapy drug product. The role requires interfacing with multiple groups, independent task execution, result interpretation, and troubleshooting. Based in Devens, MA, the position reports to the Manager, QC Analytical.

Responsibilities

• Perform routine testing of in-process, final product, and stability samples.
• Apply scientific principles to analytical testing methods and proper use of laboratory equipment.
• Ensure all testing is performed in a compliant manner.
• Review data in accordance with applicable procedures and cGMP requirements.
• Anticipate and troubleshoot problems; communicate task status, roadblocks, and needs to management.
• Support document revision, projects, CAPA, and investigation/deviation tasks.
• Perform assigned tasks within CAPA, deviation, or project initiatives.
• Lead projects and continuous improvement efforts as needed.
• Perform other assigned tasks.
• Provide shift coverage for QC and manufacturing operations, including weekdays, weekends, holidays, and adverse weather conditions.

Shift schedule: Flex shift, Monday through Friday, 10 AM to 6 PM.

Requirements

• Bachelor’s degree, preferably in Science.
• 2+ years of relevant analytical testing or QC experience (or equivalent combination of education and experience), preferably in a regulated environment.
• Hands-on experience with bioanalytical techniques (cell-based assays, flow cytometry, ELISA, qPCR) and scientific knowledge of the methods.
• Ability to accurately understand, follow, interpret, and apply Global Regulatory and cGMP requirements.
• Strong technical writing and problem-solving skills.
• Ability to work independently in a high-paced team environment, meet deadlines, and prioritize work.
• Strong communication skills with peers, management, and cross-functional teams.
• Working knowledge of LIMS.