Job Information
Actalent Sr. Quality Assurance Associate - Cell Therapy in Bothell, Washington
Job Title: Senior Quality Assurance Associate
PLEASE READ: This is not a software/QA test position. Candidates from a software/QA Automation background will not be considered. Biotech/Pharmaceutical experience is required.
Job Description
As a Senior Quality Assurance Associate, you will be instrumental in executing day-to-day quality assurance tasks to support ongoing manufacturing processes. You will be responsible for ensuring that all manufacturing operations meet quality standards and regulatory requirements, particularly within a cleanroom environment.
Responsibilities
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.
Act as 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.
Review and approve 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.
Essential Skills
Proficiency in cGMP and quality management systems.
Experience with deviations, CAPA, and change management.
BS degree with 7+ years of 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 and Lentiviral Vector manufacturing.
Experience in clinical and cGMP manufacturing.
Experience with electronic quality management systems (e.g. deviations, CAPAs, change management).
Ability to work effectively both independently and with a team to set goals, develop project plans, monitor progress, and report results.
Excellent communication, emotional intelligence, and interpersonal skills.
Strong analytical skills and scientific/technical expertise.
Additional Skills & Qualifications
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 priorities.
Desire and ability to work in a fast-paced, start-up environment.
Work Environment
This position operates in a dynamic and fast-paced environment, requiring flexibility and adaptability to changing priorities. The role demands attention to detail and a commitment to maintaining high-quality standards in manufacturing processes. You will work within a cleanroom environment and be expected to collaborate closely with cross-functional teams.
Job Type & Location
This is a Contract position based out of Bothell, WA.
Pay and Benefits
The pay range for this position is $48.04 - $48.08/hr.
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a fully onsite position in Bothell,WA.
Application Deadline
This position is anticipated to close on Mar 9, 2026.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.