Quality Operations, Senior Specialist I

Location: Cambridge, Massachusetts Salary: US$40 - US$55 per hour
Sector: Operations Type: Contract

Join this exciting and innovative Quality Operations team to aid the overall success of their gene therapy approach. They need an experienced candidate to oversee Quality Operations review of test and batch records, and quality system records that will be created during external manufacturing and testing of company products. You will support activities to make sure a timely generation of disposition documentation, so you will need to be detail oriented and extremely organized, while being a critical thinker with great communication skills.

  • You will support Quality Control Integrated Operations and External Manufacturing Operations during batch production and testing, making sure that no unexpected events are handled in the correct fashion.
  • You will prepare and then review documents associated with investigations, CAPA action plans, deviations, and OOS results.
  • You will both review and approve documents including: Process Validation protocols and Reports, manufacturing batch records in support of product release, Standard Operating Procedures.
  • You will track and trend batch execution at CMO's providing periodic updates to management.
  • You will help with the development, implementation, and the revision of corporate quality systems.
  • You must ensure all documentation complies with cGMP regulations as well as industry guidelines.
  • You must make sure that all documentation complies with cGMP regulations and industry guidelines.

  • BA/BS AND a minimum of 3-5 years in Quality Assurance/Quality Control.
  • Must have the ability to demonstrate project management skills.
  • Must have a good understanding of cell culture as well as upstream manufacturing is a plus.
  • Must have a good knowledge of quality systems, GxP regulations, and guidance documents.
  • Must have a background with disposition activities, including performing activities that support adherence to disposition timelines.
  • Must have experience with investigations, CAPA development/monitoring, deviations, and Batch Record Review.

Sthree US is acting as an Employment Business in relation to this vacancy.