Specialist I, QC Analytics (Wed-Sat Shift)
$89,440–$118,560 year
On-siteWaltham, Massachusetts, United States
Waltham, Massachusetts, United StatesOn-sitePart Time$89,440–$118,560 yearBIOTECHMedium
Part TimeMediumBIOTECH
Job Summary
Qualify, write, and review protocols for cell and molecular biology assays while executing routine molecular and cellular analytical tests. Investigate and review testing excursions, deviations, CAPAs, and OOS results. Lead drafting and review of methods and qualification/validation procedures for cellular assays such as Flow Cytometry. Work cross-functionally with Analytical Development to transfer and qualify developed assays and assist in training laboratory staff. Collaborate with other QC functions to ensure testing completion within established timelines.
Required Qualifications
- Bachelor's, or Master's, degree in a technical discipline (Biology/Chemistry/Microbiology or related field)
- minimum of 3 years of experience
- 1 years with Master's degree
- Experience with techniques such as PCR, Flow Cytometry, immunoassays, cIEF
- Significant knowledge of GMPs, SOPs, and Quality System processes
- Excellent organizational skills and attention to detail
- Ability to work independently and communicate/collaborate with scientific/technical personnel
Desired Qualifications
- Experience in a GMP QC laboratory setting
- Significant experience with flow cytometry
- Experience in a GMP QC laboratory setting and/or drafting of test methods and qualifications
- Experience working with electronic systems (LIMS, CMMS, QMS, ERP)
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.