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QA Associate II

Location: Bothell, WA
Since 2001 Hansell Tierney has been one of the premier staffing and recruiting companies in Seattle Washington. As a Certified Women’s Business Enterprise (WBE), Hansell Tierney was created to serve and staff Northwest companies by doing things the right way, not just the easiest. We strive to do better by partnering with candidates, treating your experience as one of our own, providing our candidates with interesting local opportunities, and handling every relationship with the highest level of customer service possible. Our business is built on the deep understanding of the job market and the ability to over-deliver on our promises.

We are currently helping our client with a search for a QA Associate II/III.

Duration - 6 month contract
Location - Greater Seattle area  - LOCAL CANDIDATES ONLY
US citizens and those authorized to work in the US are encouraged to apply
Work sponsorship is not available at this time

DESCRIPTION:

The QA Associate II/III position is an individual contributor role responsible for providing QA oversight of GMP operations. This includes batch record review production and associated cGMP records to assure product quality is consistent with established standards and in compliance with regulatory and industry standards.
  • Review batch production records, test results, and certificates of analysis.
    Conduct Quality on the Floor activities including quality walk-throughs of the production, testing and warehouse locations.
  • Provide Quality support to Manufacturing personnel on the floor; provide guidance during GMP events and initiation of deviation investigations.
  • Review executed batch records to ensure compliance with approved procedures and communicate and resolve discrepancies with manufacturing operators or supervisors.
  • Review deviations, product non-conformities, and GMP investigations to ensure adequate resolution and compliance with current Good Manufacturing Practices (GMPs).
  • Act as QA Subject Matter Expert (SME), and support/train cross functional groups on root cause analysis and development of corresponding corrective and preventive actions.
  • Manage the batch disposition process by ensuring that all required documents are accurately and properly completed, including all batch related deviations.
  • Oversee manufacturing operations during patient material receipt and drug product pack out.
  • Support the review and approve incoming raw materials, routine preventive and calibration of equipment.
  • Support internal and external audits, including documenting observations and oversee implementation of corresponding CAPAs.
  • Revise Standard operating Procedures as needed.
QUALIFICATIONS:
  • 2-3+ years of experience and knowledge of CGMPs and applicable FDA/EMA regulations in the biotechnology industry; experience in the cellular therapy field is preferred.
  • Hands-on experience with batch record review and product disposition.
  • Detail oriented team player with effective planning, organization and execution skills.
  • Excellent verbal and written communication skills.
  • Strong computer skills with Word and Excel; experience with E-Systems is preferred.
  • Ability to work effectively at a fast pace with cross functional departments.
  • Innovative, proactive, and resourceful; committed to quality and continuous improvement.
  • Ability to anticipate and mitigate challenges.
  • Experience with use of complex research techniques and methodologies like six sigma and Kaizen to improve process/product quality is a plus.
  • Ability to work in shifts model ( 4 days x 10 hours) is required including weekends.
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Hansell Tierney 2955 80th Ave SE Suite 102 Mercer Island WA 98040 Office: 206-232-3080 Email: info@hanselltierney.com