Senior Associate, Quality Assurance - Contract
TalentBurst, Inc.
Bothell, WA
Location: Bothell, WA
Duration: 12 Months
The Quality Assurance team is seeking a highly motivated and detail-oriented Quality Assurance Senior Associate to join our team at the Client's 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.
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.
About the Company
TalentBurst, Inc.
For over 20 years, TalentBurst Inc. has been an award-winning provider of cutting-edge Workforce Management Solutions. With a strong commitment to staying ahead in the tech landscape, we pioneer innovative approaches to talent acquisition. Our expertise spans Life Sciences, and Healthcare Staffing, Banking, Financial, IT, and Engineering, as well as Global Employer of Record (EOR), Agent of Record (AOR), State, Local Government and Education (SLED), and IC validation/compliance services. Additionally, our division, TalentProcure, leads the industry with offerings such as High Hazard Payroll, Managed Services, and Vendor on Premise (VOP) solutions.
Due to our prioritization of excellent standards, we are Joint Commission Certified and are a certified Minority Business Enterprise (MBE) in the USA and Canada. Supporting over 130 Fortune 500 companies globally, we excel in navigating the landscape of talent acquisition. In a world of constant change, we embrace developing people-centric solutions that address the unique demands of our clients. Stay connected by visiting our website and following us on social media!