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TalentBurst, an Inc 5000 company · 1 month ago

Senior Associate, Quality Assurance

Bothell, WA

Full-time

Onsite

Senior Level

$45/hr - $48.08/hr

TalentBurst, an Inc 5000 company, is seeking a highly motivated and detail-oriented Quality Assurance Senior Associate to join their team at the Client's Manufacturing Facility in Bothell, WA. This role involves performing routine Quality Assurance tasks to support ongoing manufacturing operations, including batch record review, raw material disposition, and deviation investigations.

RecruitingStaffing Agency

Growth Opportunities

H1B Sponsor Likely

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, 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

Qualification

CGMP manufacturingElectronic quality management systemsAnalytical skillsProject managementCommunication skillsProblem-solving skillsTeam collaboration

Required

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

Company

TalentBurst, an Inc 5000 company

Glassdoor4.2

Founded in 2002, TalentBurst is an MBE and JCC certified firm that provides award winning solutions globally.

Founded in 2002

Natick, Massachusetts, USA

1001-5000 employees

http://talentburst.com

H1B Sponsorship

TalentBurst, an Inc 5000 company has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (3)

2023 (7)

2021 (1)

2020 (4)