Job Specifications
Pride Health is seeking a Sr. Quality Assurance Associate for a clinical-stage cell therapy company, that develops T cell reprogramming technologies for patients with solid tumors.
Job Title: Sr. Quality Assurance Associate
Location: Bothell, WA 98021 (on-site)
Job Type: Contract
Length: 12-Months
Shift: This role requires working either a Wednesday through Saturday shift or a Sunday through Wednesday shift, 10 hours per day. Some holiday coverage may be required.
Front Half Schedule - Sunday-Wednesday 7am-5:30p
Back Half Schedule - Wednesday-Saturday 9am-5:30p
Pay Rate: $40.00 - $48.08 per hour
Overview:
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.
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.
Requirements:
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.
Preferences:
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
Benefits that Pride Health offers:
Pride Health offers eligible employee’s comprehensive healthcare coverage (medical, dental, and vision plans), supplemental coverage (accident insurance, critical illness insurance and hospital indemnity), a 401(k)-retirement savings, life & disability insurance, an employee assistance program, identity theft protection, legal support, auto and home insurance, pet insurance, and employee discounts with some preferred vendors.
Apply Today! If you are interested in the position, please email your resume to rob.vanriet@russelltobin.com for immediate consideration.
About the Company
Pride Health is a leading minority-owned healthcare recruitment & staffing firm that offers highly customized business process solutions at cost-effective prices.
Headquartered in New York City as a top minority supplier, PRIDE Health offers a broad geographic reach with offices throughout the U.S., India, and Brazil. Leveraging more than 20 years of experience, PRIDE has enhanced its core competency of IT staffing services by creating client-centric, cost-effective IT, and business process solutions. PRIDE serves Client-Pa...
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