The primary role of the Senior Specialist of Quality Assurance is to manage QA elements of our cGMP Quality System at the Cambridge facility and to provide QA support to Manufacturing operations at the Cambridge facility.
Essential job functions with respect to the Cambridge facility include:
- Management of QA documentation (e.g. Document Change Requests and Approvals, Quality Record Retention, Batch Record Issuance etc.)
- Vendor Management (e.g. Requests and Qualifications)
- Change Control Management
- Deviation Management- reviewing, revising, assisting in deviation workflow to final completion within timelines per procedures
- Perform Raw Material Release
- Perform internal audits/ self-assessments
- Perform training specifically new hire GMP training, Deviation, CAPA, Change Control writing
- Develop and revise Quality System process documents
- Support Equipment and Software Validation activities (e.g. Protocol and Report reviews and approvals) and understanding of bioinformatics process
- Review and approve completed Batch Records
- Provide Product Release Authorization
- Develop and distribute periodic Quality Metrics report
- Represent QA in interdepartmental meetings as applicable
- Participate in special projects and/or assignments as requested by Director
- Overall teamwork, collaboration, and team player to achieve results in a fast paced environment in which priorities can change through the day/week.
- Ability to negotiate terms of agreement within cross functional teams and maintain compliant systems and identify compliance related issues
- Perform self- assessments/internal audits in the lab
- The Senior Specialist of Quality Assurance will have a background in the management of Quality Systems in the biotech/pharma industry, and will have knowledge of cGMPs as they pertain to manufacturing operations preferable in personalized medicine/NGS process.
- BA/BS or equivalent degree in a scientific or healthcare related field.
- 5+ years in pharmaceutical/biotech industry experience with a particular focus on cGMP compliance and product quality.
- The ability to support daily operation activities onsite and provide assistance to the lab processing GMP samples per the timelines identified.
- Experience using electronic systems and/or implementation of systems such as MasterControl