GMP QC Analyst: Cell & Gene Therapy Testing (Assoc I-II)

Socket.dev; Waltham (MA); On-site; USD 69,000 - 100,000; Full time

Job summary

ElevateBio is seeking a QC Associate to support GMP testing in QC laboratories at our BaseCamp facility in Waltham. The role includes performing cell and molecular biology assays and basic lab maintenance to support gene and cell therapy programs.

You will perform routine testing, review data, assist in deviations/ CAPAs, and work with cross-functional teams to ensure timely completion of testing and qualification activities. The position is a 9-month contract with a competitive hourly rate.

Qualifications

• Bachelor's or Master's in Biology/related field with 1–5 years (Bachelor) or 1–3 years (Master) of GMP lab experience.
• Experience with cell and gene therapy test methodologies is preferred.
• Strong organizational skills, attention to detail, and ability to work independently and with cross-functional teams.

Responsibilities

• Perform routine GMP testing using established methods and report data.
• Peer-review data records and testing reports.
• Investigate testing excursions, deviations, CAPAs and OOSs as needed.
• Collaborate with QC and Analytical Development to meet timelines.
• Assist in drafting/editing procedures for testing and equipment.
• Assist with inventory management of reagents and daily lab operations.

Skills

GMP knowledge

PCR

Flow Cytometry

ELISA

Cell culture

Data analysis

Documentation

Education

Bachelor's degree in Biology/related

Master's degree in Biology/related

Tools

LIMS

CMMS

QMS

ERP

Job description

ElevateBio is seeking a QC Associate to support GMP testing in QC laboratories at our BaseCamp facility in Waltham. The role includes performing cell and molecular biology assays and basic lab maintenance to support gene and cell therapy programs.

You will perform routine testing, review data, assist in deviations/ CAPAs, and work with cross-functional teams to ensure timely completion of testing and qualification activities. The position is a 9-month contract with a competitive hourly rate.