QC Analytical Lab Technician

About the role

Client is seeking a QC Analytical Lab Technician in Devens, MA. The QC Lab Technician is responsible for supporting Quality Control bioanalytical testing for method validation, critical reagent qualification, in-process, release, and stability testing of clinical and commercial cell therapy drug product. This includes the ability to interface with multiple groups, the ability to independently perform tasks, interpret results, and troubleshoot. The QC Lab Technician role is stationed in Devens, MA and reports to the Manager, QC Analytical for the Devens.

Responsibilities

• Perform routine testing of in-process, final product, and stability samples.
• Use scientific principles to assist with analytical testing methods and the proper use of laboratory equipment.
• 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.
• Anticipate and troubleshoot problems. Communicate effectively with management regarding task completion, roadblocks, and needs.
• Support document revision, project, CAPA, and investigation/deviation related tasks.
• Perform assigned tasks within a CAPA, deviation, or project.
• May lead projects and continuous improvement efforts.
• Perform other tasks as assigned.
• Support for QC and manufacturing operations requires shift coverage consisting of weekdays, weekends, holidays, and during adverse weather conditions.

Qualifications

• Bachelor's degree required, 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 various bioanalytical techniques (cell based assays, flow cytometry, ELISA, qPCR) and scientific knowledge in the methods.
• Ability to accurately and completely understand, follow, interpret and apply Global Regulatory and cGMP requirements.
• Strong technical writing skills.
• Strong problem-solving ability/mentality, technically adept and logical.
• Ability to represent the interests of the group on cross-functional teams.
• Ability to work independently in a high-paced team environment, meet deadlines, and prioritize work.
• Strong ability to communicate effectively with peers, department management and cross-functional peers. Ability to work with management locally and globally.
• Working knowledge of LIMS.

Schedule

100% onsite role. Shift: 1 Flex shift, Monday through Friday, 10:00 AM to 6:00 PM.