Quality Assurance Senior Associate

The Quality Assurance team is seeking a highly motivated and detail-oriented Quality Assurance Senior Associate to join our team at our client's Manufacturing Facility 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.

Key Responsibilities

• 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, Chage 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.

Knowledge, Skills And Abilities

• 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.

PREFERRED EDUCATION:
BS degree with 7+ years' experience in a relevant field (e.g. biochemistry, chemical engineering, bioengineering, or related scientific field)

Preferred Experience

• 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

JSG offers medical, dental, vision, life insurance options, short-term disability, 401(k), weekly pay, and more. Johnson Service Group (JSG) is an Equal Opportunity Employer. JSG provides equal employment opportunities to all applicants and employees without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, marital status, protected veteran status, or any other characteristic protected by law.