LanceSoft, Inc. · 10 hours ago
QA Specialist II
Abbott Park, IL
Full-time
Onsite
Mid Level
$30/hr - $36.30/hr
3+ years expLanceSoft, Inc. is a company seeking a QA Specialist II responsible for bioanalytical quality assurance testing within the Starlims and SAP system. The role involves maintaining the quality system, conducting testing, and providing quality support to product development and improvement projects.
Information Technology
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 a 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
Quality/Compliance -Support manufacturing and testing operations as required, adhering to GMPs and GLPs. 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
Conduct business in a manner that will protect human health, safety and the environment by complying with all applicable EHS laws; as well at the client Global and Technical standards. Comply with client Quality System (QS) requirements
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
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 and experience in quality function
Demonstrate excellent communication (written and verbal) skills
Knowledge of manufacturing/testing of diagnostic products, diagnostic methods and applications, excellent troubleshooting skills, product/process improvement, stability testing, validations, technical troubleshooting, compliance, internal and external audits, and knowledge of performance metrics
Company
LanceSoft, Inc.
Established in 2000, LanceSoft is a pioneer in delivering top-notch Global Workforce Solutions and IT Services to a diverse clientele.
5001-10000 employees
H1B Sponsorship
LanceSoft, Inc. 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 (55)
2024 (32)
2023 (23)
2022 (25)
2021 (60)
2020 (80)
Funding
Current Stage
Late StageLeadership Team
Ram Karuppusamy
Chairman & CEO
Simon Dealy
Chief Financial Officer
Company data provided by crunchbase