Senior Quality Systems Specialist
On-siteCambridge, Massachusetts, United States
Job Summary
Develop, implement, and maintain QA processes for GMP manufacturing and testing across all eGenesis locations. Initiate, support, and manage deviations and CAPAs to ensure timely closure. Administer the Electronic Laboratory Notebook for batch records and test methods, while overseeing documentation management and archival. Lead organization training by administering sessions, managing matrices, and trending metrics. Participate in cross-functional teams to resolve quality issues and develop policies conforming to cGMP standards. Provide QA support to Development, Manufacturing, and Quality Control teams, including reviewing executed records and mentoring staff on regulatory requirements. Implement process improvements to enhance compliance and method quality.
Required Qualifications
- Bachelor's degree in a scientific or operational discipline relevant to the life sciences or biopharma areas
- 5+ years combined of experience in quality system management
- 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
Desired Qualifications
- Non-degreed candidates with 7+ years combined of relevant GLP/GMP quality systems experience will be considered
- Proficiency in using QA software tools and electronic Quality Management Systems (eQMS)
- Experience in Qualio, Veeva and/or Benchling
- Experience in a start-up or small company environment
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