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QA Specialist

  • Location: Massachusetts
  • Job Type:Contract

Posted 21 days ago

  • Expiry Date: 30 September 2021

​​Job Description:

  • Provides support through quality review and approval of GMP Material & service non-conformances with suspected supplier root cause.

  • Provides quality oversight of supplier complaints.

  • Reviews and approves supplier investigations and CAPAs.

  • Represents Quality in cross-functional meetings and with suppliers.

  • Assist in resolution of supplier / material related issues as they arise.

  • May perform quality review for area documents including Standard Operating Procedures, Batch Records, Material Specifications, forms and logbooks

Qualifications:

  • Knowledge of science generally attained through studies resulting in a B.S. in Science, Engineering, Biochemistry or related discipline, or its equivalent.

  • A minimum of 4 years with directly relevant experience in a regulated environment is required; biotech bulk and finished product manufacturing is highly desirable.

  • Knowledge of US and EU cGMP regulations and guidance.

  • Knowledge of quality management systems, including TrackWise or Infinity, is desirable.

  • Past experience where one was required to work in a team-based environment with a diverse group of people.

  • Excellent writing and oral communication skills are required.

About ASK: ASK Consulting is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Consulting connects people with amazing opportunities

ASK Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all associates.