QC Specialist at Softworld Inc

Job Title: QC Specialist

Job Location: Waltham MA 02451

Onsite Requirements:

• Conducting QC investigations
• QC Sample Testing
• Experience with PCR, Flow Cytometry, ELISA and Bioassay Execution

Job Description:

• The QC Associate will support cellular therapy product release testing within the QC analytical laboratory facility in Waltham.
• In this role, you will be responsible for analytical testing (cell and molecular biology assays) as well as excursion/deviation investigations and reports in support of gene and cell therapy programs.
• Additionally, the QC Associate will assist in qualifying and writing protocols for these assays.

Here's What You'll Do

• Perform routine analytical tests, analyze results, and record data/report in LIMS.
• Investigate and review analytical testing excursions, including deviations, CAPAs and OOSs.
• Collaborate with other QC functions to ensure all testing is completed within established timelines.
• Work cross-functionally with QC Analytical Development to assist in the qualification and transfer of developed assays.
• Draft test methods/SOPs.
• Assist in the training of laboratory staff

Requirements

• Bachelor's, or Master's, degree in a technical discipline (Biology/Molecular Biology/Chemistry or related field) with a minimum of 3-5 years of experience, or 2-3 years with master's degree, preferably in a GMP QC laboratory setting.
• Experience with cell and gene therapy test methodologies (qPCR/ddPCR, Flow Cytometry, ELISA, and cell-based assays).
• Excellent organizational skills and attention to detail.
• Ability to work independently and communicate/collaborate with scientific/technical personnel.
• Experience performing laboratory investigations.
• Knowledge of GMPs, SOPs, and Quality System processes.
• Experience working with electronic systems (LIMS, CMMS, QMS, ERP) is a plus.