QC Analyst - Bioassay (Temporary, 2nd shift, Wed-Sat)

Genezen•Lexington, MA

5d•Onsite

About The Position

The QC Analyst will be responsible for routine and non-routine QC testing within the Bioassay team within a GMP laboratory. This is a 2nd shift, Wednesday-Saturday, fully on-site, position (1 – 11.30pm) based at Genezen’s new state-of-the-art facility in Lexington, MA. This role supports daily operations within the Quality Control group through execution of cell-based testing, routine lab support and working within Quality Systems. This includes but is not limited to in-process testing, lot release testing, and stability testing. Support outside of standard shift hours is required occasionally and the initial work period will be on Mon-Fri. All activities are executed in accordance with cGMP guidelines and are supported by departmental and inter-departmental policies and standard operating procedures.

Requirements

BA/BS in Biochemistry/Cell Biology or other related science
Minimum 2 years’ laboratory base experience within QC testing capacity, preferably in cGMP environment.
Thorough understanding of industry testing requirements/standards
Computer literacy (MS Word, Excel, and LIMS)
Good/effective communication and organizational skills with the ability to work well with others and independently.
Strong understanding of GxP regulations, ability to apply to any situation, and identify deficiencies w/ some guidance.
Adaptability required as work schedule may change based on business needs.
Criminal background check required (completion by staffing agency satisfies this requirement).

Responsibilities

Perform routine/non-routine cell-based testing and review of in-process, DS and DP release and stability samples in accordance with Standard Operating Procedures (q-PCR, ddPCR, cell culture, ELISA)
Perform peer review as SME of assay data with minimal errors.
Participate in equipment validation, method transfer/qualification/validation, critical reagent qualification and special protocol execution as required.
Review/generate protocols and reports, as required.
Establish, revise, review and maintain standard operating procedures.
Promptly and proactively communicates gaps to leadership
Work as an active member of internal/cross-functional teams
Train other analysts, as required.