Senior Quality Assurance Specialist

17 hours ago


Bothell WA USA, United States Omni Inclusive Full time
Job Title: Senior Quality Assurance Specialist

Omni Inclusive is seeking a highly skilled Senior Quality Assurance Specialist to join our team. As a key member of our Quality Assurance Operations department, you will play a critical role in ensuring the highest standards of quality and compliance in our manufacturing processes.

Key Responsibilities:
  • Lead and facilitate deviation triages, investigations, and CAPA processes to ensure timely and effective resolution of quality issues.
  • Partner with cross-functional teams to drive on-time phase completion and ensure compliance with regulatory requirements.
  • Develop and maintain strong business partner relationships to ensure effective communication and collaboration.
  • Provide quality support to manufacturing personnel and provide guidance during GMP events and deviation investigations.
  • Review deviations, product non-conformities, and GMP investigations to ensure adequate resolution and compliance with current Good Manufacturing Practices (GMPs).
Requirements:
  • Bachelor's degree in a relevant science or engineering discipline.
  • 5-8 years of experience in oversight and execution of deviation initiation, investigations, and approvals within a quality management system.
  • Experience in cGMPs and FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred.
  • Strong communication and interpersonal skills, with the ability to work effectively in a team environment.
  • Ability to analyze complex data and make sound judgments.
What We Offer:
  • A dynamic and supportive work environment.
  • Opportunities for professional growth and development.
  • A competitive salary and benefits package.

We are an equal opportunities employer and welcome applications from diverse candidates. If you are a motivated and experienced quality professional looking for a new challenge, please submit your application.



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