Quality Assurance Specialist

5 days ago

Bothell, Washington, United States Omni Inclusive Full time
Job Title: Quality Assurance Specialist

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

Key Responsibilities:
  • Lead and facilitate deviation triage, initiation, and classification processes to ensure timely and effective resolution of quality issues.
  • Partner with cross-functional teams to investigate and resolve deviations, ensuring compliance with regulatory requirements and company policies.
  • Develop and implement corrective and preventive actions to prevent recurrence of deviations and improve overall quality.
  • Collaborate with stakeholders to ensure smooth transition of CAPAs and deviation closures.
  • Provide quality support to manufacturing personnel, including guidance during GMP events and initiation of 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.
  • 3-5 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 ability to work effectively in a team environment.
  • Ability to analyze complex data and develop effective solutions to quality issues.
Working Conditions:

The Quality Assurance Specialist will work in a fast-paced team environment, with frequent interaction with cross-functional teams. The position requires strong analytical and problem-solving skills, as well as excellent communication and interpersonal skills. The successful candidate will be able to work effectively in a team environment, with a strong focus on quality and customer satisfaction.

This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job. This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by management.

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