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Sr. Quality Operation Specialist

Senior Quality Assurance Specialist Greater Boston Area Length: 12 Month (+ Extensions)

My client is a leading biotech firm located in the Greater Boston Area. They are looking to add a Quality Operations specialist to their team to help with routine Quality Operation tasks in conjunction with other internal departments. The role is a 12 month contract with extensions. The Quality Operations specialist is tasked with overseeing batch review, and resolution of Quality systems encountered through manufacturing and testing of disposition. The Quality Operations Senior Specialist will support the organization by ensuring conformance to established quality processes and standards while actively working to continuously improve them.

Responsibilities

  • Support Manufacturing Operations during batch production Manage release testing for bluebird bio starting materials.
  • Manage data review, analysis, identification of trends, and complex problem solving.
  • Ensure an appropriate, consistent, and harmonized approach is standard across all CMOs and CTOs.
  • Review and approve documents including: Manufacturing batch records in support of product release; Standard Operating Procedures, Process Validation Protocols and Reports;
  • Prepare and review documents associated with deviations, investigations, OOS results, and CAPA action plans.
  • Track and trend quality system generation at CMOs and CTOs, providing period updates to Management - Review and approve deviations, CAPA, and Change Control, performing Failure Mode and Effect Analyses, root cause analyses, and CAPA effectiveness check as required.
  • Track and trend batch execution at CMOs, providing periodic updates to Management - alignment to target Turnaround Times and Disposition dates, number of comments and deviations per batch.
  • Identify quality issues and effectively and proactively resolve them in a diplomatic, flexible, and constructive manner.
  • Engage in activities to continuously assess and improve Lot Review and Disposition processes.
  • Support the development, implementation, and revision of corporate quality systems.
  • Ensure all documentation complies with cGMP regulations and industry guidelines.

Qualifications

  • BA/BS
  • 2-8 years of Quality Assurance Operations experience
  • Sound Quality System experience
  • Excellent knowledge of GxP regulations, quality systems and guidance documents
  • Excellent project management skills
  • Attention to detail and self-motivation
  • Experience with disposition, investigations, change control and process qualification and validation

The Quality Assurance Operations Specialist role is a fast moving role fully intending to bring this person ASAP. My client has fully opened their schedule and are actively booking interviews. If you would like to be considered for this role feel free to send over an updated version of your resume to Ahmed Hassan and team at Real Staffing, Boston.

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