COMPANY MISSION
At eGenesis, we aspire to deliver safe and effective human transplantable cells, tissue and organs utilizing the latest advancements in genome editing.
POSITION SUMMARY
The Quality Systems Specialist will be supporting the Quality Assurance team to implement and manage Quality Systems supporting GMP Manufacturing and Testing across all eGenesis locations. This position reports to the Sr. Manager of Quality Systems and is a highly visible and impactful position that will require cross-functional interaction across the multiple teams in the Organization. This position will be in Cambridge, MA.
PRIMARY RESPONSIBILITIES
- Developing, implementing, and maintaining processes to support Quality Assurance oversight for the manufacturing of cloning material to be used in clinical studies
- Ability to initiate and support the management of CAPAs, deviations, investigations etc. as well as monitor completion of such quality compliance activities
- Facilitate Change Control Review Board (Organize Stakeholders, Meeting Minutes, Tracking Timely Completion and Assisting End Users)
- Participating in cross-functional teams to resolve quality related issues impacting manufacturing activities
- Developing, trending, and reporting of relevant Quality Metrics associated with the area of responsibility
- Supporting the development of policies, processes, procedures, and controls ensuring they conform to established cGMP standards and regulatory requirements and guidelines
- Provide Quality Assurance support to many cross functional teams including Development, Manufacturing, Quality Control departments
- Provide mentoring and training to staff that are new to regulatory requirements and to facilitate their use of established quality systems
- Implement process improvements to enhance compliance and improve method and product quality processes (e.g. process tools creation, SOP revision, or enterprise systems implementation)
- Provide Quality Assurance support in reviewing/approving executed records in needed areas (Forms, Logbooks, Master Batch Records etc.)
- Perform duties regarding special projects, as assigned by Quality Management
BASIC QUALIFICATIONS
- Bachelor’s degree in a scientific or operational discipline relevant to the life sciences or biopharma areas with 3+ years combined of experience in quality system management. Non-degreed candidates with 6+ years of combined relevant GLP/GMP quality systems experience will be considered
- Knowledge of Quality Management Systems (QMS), CAPA processes, and audit procedures
- Familiarity with relevant regulations and standards (e.g., ISO, FDA, cGMP)
- Strong analytical, problem-solving, and communication skills
- Proficiency in using Quality Assurance software tools and electronic Quality Management Systems (eQMS) is a plus
- Experience in Qualio and/or Benchling preferred
- Experience in a start-up or small company environment preferred
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