Specialist I, QC Analytics (Wed-Sat Shift)

The Role:

In this lab-based role, the QC Specialist I will support product release testing within the QC analytical laboratory at our BaseCamp facility in Waltham, MA. In this role, you will be responsible for qualifying, writing/reviewing protocols for, and executing cell and molecular biology assays for ElevateBio’s gene therapy programs. Additionally, the QC Specialist I will investigate and review excursions and deviations generated during qualification and testing.

Here’s What You’ll Do:

• Work cross-functionally with Analytical Development to transfer and qualify developed assays
• Lead drafting and review of methods, and qualification/validation procedures and reports for cellular assays such as Flow Cytometry
• Perform routine molecular and cellular analytical tests; review, analyze, and communicate results
• Investigate and review analytical testing excursions including deviations, CAPAs and OOSs
• Assist in the training of laboratory staff
• Collaborate with other QC functions to ensure all testing is completed within established timelines

Requirements:

• Bachelor’s, or Master’s, degree in a technical discipline (Biology/Chemistry/Microbiology or related field) with a minimum of 3 years of experience, or 1 years with Master’s degree
• Experience in a GMP QC laboratory setting is preferred
• Experience with techniques such as PCR, Flow Cytometry, immunoassays, cIEF required
• Significant experience with flow cytometry is strongly preferred
• Experience in a GMP QC laboratory setting and/or drafting of test methods and qualifications is strongly preferred
• Excellent organizational skills and attention to detail
• Ability to work independently and communicate/collaborate with scientific/technical personnel
• Significant knowledge of GMPs, SOPs, and Quality System processes. 
• Experience working with electronic systems (LIMS, CMMS, QMS, ERP) is a plus

The budgeted range for this position is $43/hour - $57/hour. This range is a good faith estimate of the expected hourly range for this position, based on a wide range of factors including qualifications, experience and training, operational and business needs and other considerations permitted by law.