QA Associate in Bothell, WA at Apex Life Sciences

Date Posted: 5/14/2018

Job Snapshot

Job Description

Apex Life Sciences is looking for a Quality Associate for one of the fastest growing biotech companies in Bothell. Please see below and apply if interested!

Job Description:

  • 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.

Basic Qualifications:

  • 2+ (II) 3+(III) 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.

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at or 844-463-6178.