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Homology Medicines, Inc. Senior Quality Control Lead - Microbiology in Bedford, Massachusetts

The HMI Senior Quality Control (QC) Lead will assist the QC Managers with schedule adherence and execution of routine QC Microbiology sampling and testing of the GMP clinical manufacturing facility for gene therapy and gene editing products. The individual will collaborate cross-functionally on Quality Systems, such as OOS/OOT, deviations, change controls and

risk assessments, as well as lead verification and validation of microbiological methods.

They will demonstrate subject matter expertise in microbiological testing. They will work cross functionally with groups such as Manufacturing, Facilities or Engineering to resolve and communicate issues in a timely fashion. This person will train, coach, and mentor analysts and associates within QC. They will be capable of interpreting and communicating new and historical testing data. They will demonstrate department ownership through a cooperative and collaborative approach. The incumbent must be detail- oriented and be able to read and execute written instructions with precision. Strong written and verbal communication skills are required. The ideal candidate is a cooperative team player with excellent interpersonal skills, energy, integrity, and initiative.

  • Maintains schedule for environmental and utilities monitoring activities.

  • Oversees and executes routine QC Microbiology testing including not limited to: Bioburden, Endotoxin, TOC, Growth Promotion, Biological Indicators,

  • Leads qualification/validation of microbiological methods (bioburden, endotoxin,etc.) as well as other technical projects/studies aimed at maturing HMI’s microbial control quality system.

  • Leads and executes environmental, utility, and product excursion investigations (Alert, Action and OOS)

  • Authors Quality Systems (deviations, CAPAs, and change controls) and risk assessments with assistance

  • Trends environmental and utility monitoring data and generates reports

  • Authors and revises SOPs/Forms and other relevant controlled documentation.

  • Performs peer review of both internal and external generated data

  • Assist with leading cross-functional team activities (e.g. Environmental Action Team)

  • Train, coach, and mentor team members

  • Supports routine laboratory operations (equipment cleaning, laboratory cleaning,

  • inventory control, logbook management)

  • Participates in laboratory equipment qualification activities, as needed.

  • Ensures laboratory operational efficiency and productivity and assists with troubleshooting/continuous improvement

  • Ensures all tasks are performed in a manner consistent with safety standards.

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

  • Minimum 5 years of experience in the biotech industry

  • Hands on experience in environmentally controlled areas

  • Hands on experience utilizing aseptic technique and experience with aseptic

  • manufacturing (gowning qualification, aseptic process simulation)

  • Experience with data review and presenting results to functional management

  • Experience generating/revising/reviewing microbiological SOPs, technical

  • documents, protocols, and investigations.

  • Experience in microbiological method verification and validation.

  • Independently motivated, detail oriented and strong problem-solving ability

  • Able to work effectively in a collaborative team environment

Job ID: 2021-1170

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