GMP QC Associate I (Cell & Gene Therapy)

ElevateBio; Waltham (MA); On-site; USD 45,000 - 59,000; Full time

Job summary

ElevateBio is seeking a QC Associate to support GMP testing in QC laboratories at the BaseCamp facility in Waltham. You will perform cell and molecular biology assays and assist in maintaining lab operations for gene and cell therapy programs.

Responsibilities include routine testing, data recording, peer-review, investigations of excursions, deviations, CAPAs and OOSs, and cross-functional collaboration to qualify assays. Prior GMP experience and familiarity with LIMS/QMS/ERP are a plus.

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 in GMP setting preferred.
• Experience with cell and gene therapy test methodologies (PCR, Flow Cytometry, ELISA, cell culture, cell-based assays).
• Excellent organizational skills and attention to detail.
• Ability to work independently and collaborate with 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.

Responsibilities

• Perform routine testing using established test methods and report data.
• Peer-review data records and testing reports.
• Assist with investigating testing excursions, deviations, CAPAs and OOSs.
• Collaborate with QC to meet timelines.
• Share responsibility for inventory and daily lab operations.
• Assist qualification of developed assays with Analytical Development.
• Draft or edit procedures for testing and/or equipment.

Skills

Cell & molecular biology

GMP experience

Test methods: PCR

Flow Cytometry

ELISA

Cell culture

Cell-based assays

Organizational skills

Independent worker

LIMS/CMMS/QMS/ERP exposure

Education

Bachelor’s or Master’s in Biology/Biochemistry/Chemistry

Tools

LIMS

CMMS

QMS

ERP

Job description

ElevateBio is seeking a QC Associate to support GMP testing in QC laboratories at the BaseCamp facility in Waltham. You will perform cell and molecular biology assays and assist in maintaining lab operations for gene and cell therapy programs.

Responsibilities include routine testing, data recording, peer-review, investigations of excursions, deviations, CAPAs and OOSs, and cross-functional collaboration to qualify assays. Prior GMP experience and familiarity with LIMS/QMS/ERP are a plus.