Quality Control Associate Molecuar Biology Shift (Mon - Fri)

Job Locations US-MA-Bedford
ID
2021-1172
Category
Quality Control
Type
Full Time Salary

Overview

The HMI Quality Control (QC) Associate will be responsible for supporting the routine in process, release, and stability capabilities of the QC Laboratory for internally manufactured gene therapy and gene editing therapeutics. The individual will work cross-functionally to support execution of routine analytics program for GMP operations of a Clinical Phase 1/2 manufacturing facility.

Responsibilities

  • Performs routine QC testing including, but not limited to: ddPCR, cell-based assays, ELISA, HPLC, CE and compendia test methods in support of in-process, release, and stability.
  • Supports routine laboratory operations (equipment cleaning, laboratory cleaning, inventory control, logbook management)
  • Authors and Revises SOPs/Forms and other relevant controlled documentation
  • Performs peer review of both internal and externally generated data
  • Assists with the method qualification and method transfers as needed,
  • Ensures laboratory operational readiness and assists with troubleshooting/continuous improvement as needed.
  • Ensures all tasks are performed in a manner consistent with safety standards.

Qualifications

  • Bachelor’s degree in life sciences, engineering, or equivalent
  • Minimum 0-2 years of experience in the biotech industry
  • Hands on experience in cGMP environment preferred.
  • Experience with data review.
  • Experience creating/revising/reviewing SOPs, technical documents, protocols, and investigations.
  • Independently motivated, detail oriented and strong problem-solving ability

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