An exciting and euthanistic Pharmaceutical company located in Boston, MA. Is hiring for a Sr Quality Specialist or Manger to join them on their team to provide QA support of manufacturing operations, analytical laboratory operations and materials management for the external Cell & Genetic Therapeutic programs. This role will review & support activities related to product disposition including review of batch data, batch records, deviations, in-process data. This is an onsite 6 month contract with the chance to expand looking to start around JAN 2023.
Additional responsibility that the candidate may inquire perform activities to ensure compliance with applicable quality objectives and regulatory requirements including:
Following Requirement:
- Support QA execution of process and OOS investigations, and associated CAPAs.
- Supports change control assessments, implementation, and closure.
- Support Cell & Genetic Program and Quality projects including Quality system, protocol and test data review and manufacturing process/SOP improvements
Education and Experience:
- Bachelor's degree in scientific or allied health field (or equivalent degree)
- Typically requires 3-4 years of Quality Assurance experience, or the equivalent combination of education and experience.
- Expanded conceptual knowledge of cGMP's in a pharmaceutical setting.
Please apply with your most up to date resume to be considered.
...
