Generis Tek Inc · 1 day ago
QA Specialist II
Abbott Park, IL
Full-time
Onsite
Mid Level
3+ years expGeneris Tek Inc is a boutique IT/professional staffing company based in the Chicago area, and they are seeking a QA Specialist II for their client in Abbott Park, IL. The role involves ensuring the effectiveness of the quality system, conducting quality testing, and supporting compliance with Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs).
Information Technology & Services
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 Abbott Global and Technical standards. Comply with Abbott 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
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
Knowledge of performance metrics
Experience with bioanalytical techniques: HPLC, SDS-PAGE, Western Blot, Dot Blot, ELISA, Mass Spectrometry (MS), and microtiter plate methods
Company
Generis Tek Inc
Generís Tek is an elite IT staffing firm headquartered in Chicago, IL offering long-term, short-term, temporary-to-permanent and direct placement staffing.
51-200 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase