Associate I, QC Analytics (Contract)

ElevateBio • Waltham, MA

5d • Onsite

About The Position

The QC Associate will support GMP testing in QC laboratories at ElevateBio’s BaseCamp facility in Waltham. The role performs cell and molecular biology assays and basic laboratory maintenance supporting gene and cell therapy programs. The QC Associate may also assist in qualifying assays developed with Analytical Development and other QC functions.

Requirements

• Bachelor’s or master’s degree in a technical discipline such as Biology, Molecular Biology, Biochemistry, Chemistry, or a related field.
• 1–5 years of experience with a bachelor’s degree, or 1–3 years with a master’s degree.
• Experience with cell and gene therapy test methodologies such as PCR, flow cytometry, ELISA, cell culture, and cell-based assays.
• Excellent organizational skills and attention to detail.
• Ability to work independently and communicate and collaborate with scientific and technical personnel.
• Experience performing laboratory investigations.
• Knowledge of GMP, SOPs, and Quality System processes.

Nice To Haves

• Experience working in a GMP setting.
• Experience working with electronic systems such as LIMS, CMMS, QMS, or ERP.

Responsibilities

• Perform routine testing using established test methods, analyze results, and record and report data.
• Peer-review data records and testing reports.
• Assist with investigating and reviewing testing excursions, including deviations, CAPAs, and OOSs.
• Collaborate with other QC functions to complete testing within established timelines.
• Share responsibility with peers for managing inventory and reagents and performing maintenance and other daily laboratory operations.
• Work cross-functionally with Analytical Development and other QC functions to assist in qualifying developed assays.
• Assist in drafting or editing procedures for testing and equipment.

What This Job Offers

• Career Level: Entry Level