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QA Specialist - Site Based; Redmond, WA

Evotec
Redmond, WA Full Time
POSTED ON 2/28/2025
AVAILABLE BEFORE 3/29/2025
QA Specialist - Operations - Redmond, WA

This role is responsible for the execution of day-to-day QA responsibilities for GMP manufacturing, along with building and enhancing the quality assurance systems. The role incumbent works both independently and collaboratively with Manufacturing, Quality and Facilities staff to ensure compliance with cGMPs and internal procedures. The responsibilities of the employee is based on the assigned QA organization as outlined below.

Responsibilities: QA Operations

  • Review executed Manufacturing Batch Records
  • Execute compliance walkthrough of the Manufacturing floor and other assigned areas.
  • Create and improve relevant training
  • Triage Manufacturing events and support event investigations.
  • Review and approve Master Batch Records and other supporting documents.
  • Support internal and client audits.
  • Execute process performance and product quality monitoring programs.
  • Alert senior management of significant quality, compliance, supply, and safety risks.
  • Approve quality events of eQMS (Deviations, Change Control, CAPA, Risk Assessment, Management Review, Complaint Investigation, Product Quality Review etc.) to assure compliance with regulatory and Just-Evotec Global Quality Management Systems (G-QMS) requirements.

Qualifications

  • Bachelor’s degree in biological or engineering science and 3 years of experience OR Associates degree and 5 years of relevant quality experience OR High school Diploma/GED and 9 years of relevant quality experience
  • Ability to collaborate and communicate cross-functionally.
  • Proven attention to detail

This job description is intended to describe the general content of the job, and to identify the essential functions of and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Because job requirements evolve with the changing needs of Just-Evotec Biologics business, this description is subject to change and may be modified at any time, whether formally or informally.

The base pay range for this position at commencement of employment is expected to be $78,000 to $86,250; Base salary offered may vary depending on the individual’s skills, experience and competitive market value. Additional total rewards include discretionary annual bonus, comprehensive benefits to include Medical, Dental and Vision, short-term and long-term disability, company paid basic life insurance, 401k company match, flexible work, generous paid time off and paid holiday, wellness and transportation benefits.

Evotec (US) Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, gender, age, disability, genetic information, gender expression, gender identity, national origin, religion, sexual orientation, or veteran status.

Salary : $78,000 - $86,250

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