Overview
Supplier Quality Compliance Auditor Jobs in St. Louis, Missouri, USA at Kindeva Drug Delivery
Location: St. Louis
At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world.
The Impact You Will Make
The Supplier Quality Compliance Auditor will be responsible for leading on-site and remote supplier audits and completing qualifications of new suppliers for global Kindeva. In addition, negotiate Supplier Quality Agreements, write Supplier Risk Assessments, review Supplier Material Safety Risk Questionnaires and fill out Material Safety Risk Summaries, maintain documentation for supplier oversight and summarize documentation for supplier scorecards and reassessments.
Role Responsibilities
Manage supplier qualification status in the Quality Tracking System (QTS) including entry of suppliers, creation of supplier channels, and completion of qualification tasks in QTS.
Maintain the Approved Supplier List and GMP Materials Supply Chain.
Lead on-site and remote quality audits for suppliers.
Assist with supplier audit schedule, agendas, reports, and CAPA requirements.
Work with suppliers for completion of Material Safety Risk Questionnaires.
Draft and execute quality agreements per procedures.
Maintain updated contact information for supplier contacts.
Develop colleagues on the use of quality systems as they pertain to Supplier Management.
Conduct investigations on behalf of Supplier Quality Management where needed.
Responsible person for site change controls applicable to Supplier Quality Management (where applicable).
Work closely with the Procurement department and Quality Engineers on supplier issues.
Conduct yearly Quality Agreement and Technical Agreement Annual Product Records Review report.
Basic Qualifications
2+ years in a Quality position within the pharmaceutical or medical device industry.
Must have working knowledge of 21
CFR parts 210 & 211, 820.
Ability to travel 25% to perform supplier audits in US and International locations as needed.
Preferred Qualifications
Working knowledge of ISO 13485 and ISO 1725.
Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.
Do you see yourself as part of the Kindeva mission? Click Apply Now Today!
Job Family: Quality – Supplier Quality Compliance
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Title: Supplier Quality Compliance Auditor
Company: Kindeva Drug Delivery
Location: St. Louis, Missouri, USA
Category: Quality Assurance – QA/QC, Healthcare
