QA Specialist II jobs in United States
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Select Source International · 1 day ago

QA Specialist II

Select Source International (SSI) is a distinguished staffing company with nearly 25 years of experience, renowned for delivering top-tier workforce solutions. They are seeking a QA Specialist II to implement and maintain the effectiveness of the Quality system, conduct quality testing, and manage product and process improvements in a laboratory environment.

ConsultingFinancial ServicesInformation Technology
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H1B Sponsor Likelynote

Responsibilities

Responsible for implementing and maintaining the effectiveness of the Quality system
Complete Quality testing as appropriate for products per procedures and review all data to determine conformance with specifications. Work in a high-paced laboratory environment and has multiple certifications
Experience with the following is bioanalytical techniques are a hard requirement: HPLC, SDS-PAGE, Western Blot, Dot Blot, ELISA, Mass Spectrometry (MS), and microtiter plate methods
CAPA - Investigates standard testing out of tolerance and out of specification results including complaints. Supports ticket trending process and maintains quality records
Communications - Communicate and collaborate effectively within the team and management
Documentation - Maintain accurate and complete documents and records
Manage Product and Process Improvements - Participate in project and process improvement activities. Monitor performance of testing processes, implement process improvements, and foster a culture of continuous improvement. Supports work area processes and product development/improvement projects. Provide quality support to key processes and product development/improvement projects
Takes a lead in the lab to ensure Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs) are executed and the lab is running efficiently
Management of Computer Systems - Maintain and update relevant computer applications
Possess a basic understanding of the Quality System; including the subsystems and is familiar with the Quality System Key processes. Keep abreast of the standards that regulate our industry
Participate and take all training and reviews as required on ISOtrain Learning Management System
Share Quality Knowledge - Shares quality knowledge, liaising with colleagues within team
Training - Undertakes all training and reviews as required
Sample & File Storage - Ensures storage of samples and documents in the appropriate filling systems
Lab Safety – Participates in lab safety

Qualification

HPLCMass SpectrometryELISAManufacturing PracticesQuality SystemTechnical TroubleshootingProcess ImprovementLab SafetyCommunication SkillsDocumentation

Required

Bachelor's in a science or closely related discipline with 3-4 years' experience
Experience with bioanalytical techniques: HPLC, SDS-PAGE, Western Blot, Dot Blot, ELISA, Mass Spectrometry (MS), and microtiter plate methods
Healthcare industry experience in quality function
Excellent communication (written and verbal) skills
Knowledge of manufacturing/testing of diagnostic products, diagnostic methods and applications
Excellent troubleshooting skills
Product/process improvement experience
Stability testing experience
Validations experience
Technical troubleshooting skills
Compliance knowledge
Internal and external audits knowledge
Knowledge of performance metrics

Company

Select Source International

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Select Source International (SSI) is an award-winning global leader in Consulting and Staff Augmentation, helping businesses thrive across IT, Healthcare, Finance & Accounting, Human Resources, Engineering, Energy & Utilities, Manufacturing, Administrative, Operations & Logistics, and more.

H1B Sponsorship

Select Source International 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 (2)
2024 (2)
2023 (3)
2022 (2)
2020 (4)

Funding

Current Stage
Late Stage
Company data provided by crunchbase