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Specialist Quality Operations

  • Type Contract
  • Salary US$55 - US$85 per hour
  • Location Cambridge, Massachusetts
  • Sectors Quality Assurance (QA)

Specialist, Quality Operations

Responsibilities

  • You will be overseeing not only batch review, but also the resolution of quality systems which will be encountered during external manufacturing as well as testing of company products.
  • You will need to maintain an external manufacturing vendor relationship, as well as communicate to support both efficient and compliant processes.
  • You will be responsible for the management of analysis, complex problem solving, data review, and identification trends.
  • You must ensure that any and all documentation is up to date with cGMP regulations as well as industry guidelines,
  • You will be responsible to track and trend both Batch execution at CMO's as well as quality system generation at CMO's and CTO's.
  • You will support the revision, development, and implementation of corporate quality systems.
  • You will be responsible for the preparation and review of investigations, OOOS results, quality system documentation associated with deviations, and CAPA action plans.

Qualifications

  • A background in processing and upstream manufacturing, and cellular therapy collection is preferred, but not required
  • You will need a BA/BS, as well as 5-8 years in Quality Assurance.
  • You will need experience with external manufacturing quality oversight.
  • You should have experience with process mapping, process improvement tools, and contract manufacturing.
  • You will need to have the ability to interact with contract testing and contract manufacturing organizations, including resolving, identifying, and communicating complex issues.
  • Must have the ability to demonstrate project management skills
  • You will need experience with change control, disposition, deviation investigations, and process improvements.
  • Must have the ability to communicate both above and below level in a way that caters relationship building, this will also be needed while dealing with outside vendors.
  • Must obtain a strong knowledge of quality systems, GxP regulations, and guidance documents.

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