Senior Quality Assurance Associate

Description

- Execute the Day-to-Day Quality Assurance Tasks to Support Ongoing Manufacturing: - 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

cgmp, quality management system, deviations, CAPA, change management, Gmp

Top Skills Details

cgmp,quality management system,deviations,CAPA,change management

Additional Skills & Qualifications

- 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 - 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.

Experience Level

Expert Level

This is a Contract position based out of Bothell, WA.

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)

This is a fully onsite position in Bothell,WA.

This position is anticipated to close on Dec 19, 2025.

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 for other accommodation options.

Salary : $48 - $48