Quality Assurance Specialist

Barrington James; Seattle (WA); On-site; USD 80,000 - 100,000; Part time

Job summary

A leading biotech company in Seattle is seeking a highly motivated Quality Specialist. This role involves supporting key Quality Systems activities including investigations, CAPAs, and change control within a GMP-controlled environment. The ideal candidate has experience with quality systems, excellent communication skills, and thrives in a compliance-focused atmosphere. This contract position emphasizes maintaining high standards of quality and compliance.

Qualifications

• Experience working with GMP, biotech, or other regulated life-science industries.
• Strong understanding of key quality system elements.
• Excellent technical writing, documentation, and communication skills.

Responsibilities

• Lead and support investigations by gathering data and performing root-cause analysis.
• Author and manage CAPAs to ensure effective corrective and preventive actions.
• Collaborate cross-functionally to resolve quality issues.

Skills

Experience with GMP

Technical writing

Analytical skills

Problem-solving

Attention to detail

Job description

We are seeking a highly motivated and detail-oriented Quality Specialist to support key Quality Systems activities, including deviations/investigations, CAPAs, and change controls, within a regulated biotech and GMP‑controlled environment. This role plays a critical part in ensuring product quality, compliance, and continuous improvement across operations.

Key Responsibilities:

• Lead and support investigations by gathering data, performing root‑cause analysis, and developing well‑structured, scientifically sound conclusions.
• Author, manage, and execute CAPAs to ensure effective and sustainable corrective and preventive measures.
• Initiate, assess, and manage change controls, ensuring changes are evaluated for regulatory, quality, and operational impact.
• Collaborate cross‑functionally with Manufacturing, Quality Control, Engineering, and other teams to drive timely resolution of quality issues.
• Prepare clear, accurate, and compliant documentation that meets internal standards as well as FDA, EU, and other global regulatory expectations.
• Ensure all quality records are completed within required timelines and maintained in an audit‑ready state.
• Support continuous improvement projects aimed at strengthening quality systems and operational efficiency.

Qualifications:

• Experience working with GMP, biotech, or other regulated life‑science industries.
• Strong understanding of key quality system elements (deviations, investigations, CAPAs, change control).
• Excellent technical writing, documentation, and communication skills.
• Strong analytical and problem‑solving abilities with a high level of attention to detail.
• Ability to work independently, manage multiple priorities, and interact effectively with cross‑functional teams.

This position is ideal for an individual who thrives in a quality‑focused environment, enjoys investigative problem‑solving, and is committed to maintaining the highest standards of compliance and accuracy.

Seniority Level

Associate

Employment Type

Contract

Job Function

Quality Assurance

Industries

Biotechnology Research and Pharmaceutical Manufacturing

Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, protected veteran status, or disability status.