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Homology Medicines, Inc. Floor QA Operations Sr. Associate (Shift work) in Bedford, Massachusetts

The QA Sr. Associate will provide on the floor support in partnering with manufacturing staff to establish a right-the-first-time quality culture, deliver real time batch record review, and enable efficient issue resolution in support of our novel AAV gene therapy manufacturing platform. The ideal candidate will thrive in a dynamic environment and will bring value by balancing quality and efficiency during day-to-day operations. This role includes: Quality oversight of manufacturing operations, real time batch record review, timely resolution of quality system records, and ongoing facility support. This is a 4 day/10 hr first shift position (Sun to Wed or Wed to Sat) with flexibility required during onboarding.

  • On the floor Quality presence during manufacturing operations from thaw to fill/finish

  • Champion a Culture of Quality and ensure a safe working environment

  • Batch record review and approval

  • Streamlined release of raw materials and single-use components

  • Quality System record (e.g. deviations, CAPAs…etc) support and resolution

  • Review and approve records related to Calibration/Maintenance, Materials Management, Change Management, and Quality Control

  • Support tracking and trending of metrics critical to operations

  • Support inspections and partner audits

  • Bachelor’s degree in life sciences, engineering, or equivalent

  • Minimum 3 years of experience in the pharmaceutical or biotech industry in QA operations and direct experience working with Quality Systems, specifically batch record review and deviations/CAPAs

  • Direct experience with biologics Drug Substance and Drug Product manufacturing

  • Knowledge of GMP regulations and guidelines

  • Ability to problem solve, and work autonomously in a dynamic manufacturing environment

  • Ability to apply a phase appropriate, risk-based approach to QA operational decisions

  • Excellent technical, organizational, communication, and interpersonal skills are essential

  • Flexibility to accommodate to rapidly changing priorities and deadlines

  • Final Fill, packaging, and labelling experience a plus

Job ID: 2020-1128