Job Information
TEKsystems IT Supplier Quality Engineer in North Chicago, Illinois
ROLE REQUIRES 4 DAYS PER WEEK ONSITE IN NORTH CHICAGO IL
Description:
The IT Supplier Quality Compliance Professional contractor will support the Technology Vendor Risk Management (TVRM) process. Primary Activities include reviewing and approving risk questionnaires (inherent and due diligence) received from vendors, evaluating supplier records and processing supplier files following the established TVRM process. The IT Supplier Quality Engineer will work as part of the clients Quality, Regulatory and Compliance team to review vendor documentation, provide feedback to business stakeholders and support implementation and tracking of corrections, Corrective Action/Preventative Action plans and modes of control. Candidates should have a solid understanding of GDP and GxP in life science or pharmaceutical industries.
Skills:
gdp, GxP, Third Party Assessment
Top Skills Details:
gdp,GxP,Third Party Assessment
Additional Skills & Qualifications:
REQUIRED:
Review vendor documentation to support TVRM program including:
• Risk questionnaire responses received from vendors (both inherent and due diligence)
• Internal business documentation of risk acceptance and mitigations
• Inputs to Approved Supplier List
• Vendor audit reports and assessments
Provide feedback to business stakeholders and TVRM program:
• Completeness and supporting objective evidence for vendor questionnaires
• Identifying discrepancies with vendor risk rating (justification of overall risk rating)
• Identifying compliance gaps (with respect to GDP and completeness) with vendor documentation (including audit/assessment reports)
Provide support to QRC (Quality/Regulatory/Compliance) Implementation team:
• Tracking of open implementations (modes of control, corrections, corrective/preventive actions, effectivity checks)
• Collaboration with stakeholders (internal and external) on compilation of objective evidence for completion
• Use of e-QMS system to document completion of activities (including confirmation and routing for approvals)
PREFERRED (not required):
Supplier/Vendor Quality Management experience, including site audits of critical suppliers.
o Knowledge or relevant experience working with Quality Systems/GxP-impacting assessments and audits
o Working knowledge of regulations and/or standards applicable to conduct the vendor assessments
Core Job Responsibilities
• Review and approve vendor related documentation to support the TVRM Program
• Provide communication and status to QRC management of workload items
• Support QRC Implementation tasks as assigned
• Collect necessary data to report metrics as define
About TEKsystems:
We're partners in transformation. We help clients activate ideas and solutions to take advantage of a new world of opportunity. We are a team of 80,000 strong, working with over 6,000 clients, including 80% of the Fortune 500, across North America, Europe and Asia. As an industry leader in Full-Stack Technology Services, Talent Services, and real-world application, we work with progressive leaders to drive change. That's the power of true partnership. TEKsystems is an Allegis Group company.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.