GMP QC Associate I: Cell & Gene Therapy Lab

ElevateBio; Waltham (MA); On-site; USD 45,000 - 66,000; Full time

Job summary

ElevateBio’s QC Associate will support GMP testing in QC laboratories at our BaseCamp facility in Waltham. You will perform cell and molecular biology assays and assist in maintaining labs for gene and cell therapy programs.

You may help qualify assays and collaborate with Analytical Development and other QC teams to meet timelines. The role emphasizes documentation, data review, and procedure improvements.

Qualifications

• Bachelor’s, or Master’s degree in a technical discipline (Biology/Molecular Biology/Biochemistry/Chemistry or related field). 1-5 years of experience with a Bachelor’s, 1-3 years with a Master’s.
• Experience working in a GMP setting preferred.
• Experience with cell and gene therapy test methodologies (i.e. PCR, Flow Cytometry, ELISA, cell culture, cell-based assays).
• Excellent organizational skills and attention to detail.
• Ability to work independently as well as communicate and collaborate with scientific/technical personnel.
• Experience performing laboratory investigations.
• Knowledge of GMP, SOPs, and Quality System processes.
• Experience working with electronic systems (LIMS, CMMS, QMS, ERP) is a plus.
• Multiple positions available at Associate I level.
• Contract length is 9 months.

Responsibilities

• Perform routine testing using established test methods, analyze the results, and record/report the data.
• Perform peer-review of data records and testing reports.
• Assist with investigating and reviewing testing excursions, including deviations, CAPAs and OOSs.
• Collaborate with other QC functions to ensure all testing is completed within established timelines.
• Share responsibility with peers to manage inventory and reagents, and perform maintenance and other daily lab operations.
• Work cross-functionally with Analytical Development and other QC functions to assist in the qualification of developed assays.
• Assist in drafting and/or editing procedures for testing and/or equipment.

Skills

GMP experience

Lab testing

Cell/gene therapy knowledge

Independent working

Collaboration with scientists

Education

Bachelor’s or Master’s in Biology or related field

Tools

LIMS

CMMS

QMS

ERP

Job description

ElevateBio’s QC Associate will support GMP testing in QC laboratories at our BaseCamp facility in Waltham. You will perform cell and molecular biology assays and assist in maintaining labs for gene and cell therapy programs.

You may help qualify assays and collaborate with Analytical Development and other QC teams to meet timelines. The role emphasizes documentation, data review, and procedure improvements.