Senior Associate, Quality Assurance

2525 223rd Street Southeast Bothell, WA 98021 US

Posted: 12/09/2025 2025-12-09 2026-01-08 Employment Type: Contract Job Category: Quality and Compliance Job Number: 624337 Is job remote?: No Country: United States

Job Description

Duties:

The Quality Assurance team is seeking a highly motivated and detail-oriented Quality Assurance Senior Associate to join our team at the Manufacturing Facility, LyFE in Bothell WA.

This individual will perform routine Quality Assurance tasks including but not limited to batch record review, raw material disposition, deviation investigation, CAPA, and change control approval, and other Quality Operations functions.

This role requires working either a Wednesday through Saturday shift or a Sunday through Wednesday shift, 10 hours per day, and is an onsite role with no remote work option.

• Review and approve executed electronic batch record comments and resolve discrepancies with manufacturing personnel.
• Review and approve executed test results, perform review tasks in the laboratory information management system to issue Certificates of Analysis (COAs) as applicable.
• Provide quality support for manufacturing operations in the cleanroom.
• Be a quality point of contact for process support escalations, troubleshooting, triage and resolution.
• Perform routine hands-on QA activities such as intake of incoming patient apheresis and drug product pack-out activities.
• Compile, review and approve lot disposition records.
• Perform routine raw material disposition and approve raw material specifications.
• Perform review and approval of Deviation, Change Control, CAPA, Excursion and Nonconformance record deliverables (as applicable).
• Promote a culture of safety and GMP compliance.
• Identify opportunities for continuous improvement.
• Provide support to complex change controls (as applicable).
• Support Process and/or Method Qualification and Validation activities by providing quality review of associated protocols, data and reports.
• Perform internal audits (as applicable).
• Support operational excellence initiatives.

Skills:

• Experience in clinical and cGMP manufacturing required.
• Experience with electronic quality management systems (e.g. deviations, CAPAs, change management) required.
• Ability to work effectively both independently and with a team to set goals, develop sound project plans, monitor progress, and report results.
• Excellent communication, emotional intelligence and interpersonal skills.
• Motivated and organized critical thinker with solid cross-collaboration and business communication skills.
• Fast learner, adaptable, with creative problem-solving skills.
• Ability to work efficiently, prioritize workflow, meet deadlines and balance competing.
• The desire and ability to work in a fast-paced, start-up environment.
• Excellent analytical skills and scientific/technical expertise.

Education:

• BS degree with 7+ years experience in a relevant field (e.g. biochemistry, chemical engineering, bioengineering, or related scientific field).
• 4-6+ years of experience in GMP biopharmaceutical operations with a minimum of 2+ years in GMP quality.
• Proficiency using multiple digital GMP platforms.
• Familiarity with Cellular Therapy manufacturing.
• Familiarity with Lentiviral Vector manufacturing.

Pay Rate Range: $35-48/hr depending on experience

Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.

Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.

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