The Contractor, Quality Assurance Associate – Vendor Management is responsible for supporting and executing vendor quality management activities within the Pharmaceutical Quality System. The consultant will provide hands-on QA support for the qualification, approval, maintenance, and periodic evaluation of suppliers, vendors, contractors, and service providers supporting GxP operations. The position will have a primary focus on vendor qualification and remediation activities, including completion and remediation of vendor qualification packages, quality risk assessments, vendor audits, Quality/Technical Agreements (QTAs), vendor change notifications, and periodic vendor reviews. The successful candidate is expected to bring prior hands-on pharmaceutical Quality Assurance and vendor management experience and be able to independently manage assigned vendor qualification activities through completion with appropriate QA Lead oversight. This position reports to the QA Lead, Vendor Management, Engineering & Facilities. This is a third-party hire contract role.
Essential Duties and Responsibilities:
Execute vendor quality management activities in accordance with company procedures, cGMP requirements, and applicable Quality Systems.
Perform qualification, requalification, remediation, and periodic review of GxP vendors, including completion and maintenance of qualification packages and supporting documentation.
Conduct risk assessments of new and existing vendors and suppliers.
Plan, conduct, and/or support vendor audits.
Draft, review and negotiate Quality Technical Agreements (QTAs), working cross-functionally and with vendors to drive agreements through execution and closure.
Review and assess vendor change notifications for GxP and quality impact and initiate, manage, and track associated change controls, as required.
Maintain complete, accurate, traceable, and inspection-ready vendor quality records and support continuous improvement of the Vendor Quality Management Program.
Support internal and external audits, regulatory inspections, and inspection-readiness activities, and collaborate with cross-functional stakeholders to address vendor quality and compliance requirements.
Other QA support activities as assigned or needed
Education & Experience:- Bachelor’s degree in a Scientific Field
- Minimum 2 years of direct, hands-on experience in pharmaceutical vendor/supplier quality management, including vendor qualification, risk assessment, periodic review, and maintenance of vendor qualification documentation.
- Demonstrated hands-on experience completing and/or remediating vendor qualification packages.
- Demonstrated experience reviewing, negotiating, and/or driving Quality Technical Agreements.
- Experience assessing GxP vendor change notifications.
- Excellent writing skills and command of the English language.
- Proficiency in Microsoft office software and electronic quality management systems (eQMS).Strong organizational skills a must.
- Vendor auditing experience a plus.
Physical Requirements:
The physical requirements of the position generally include standing, walking, sitting, using hands and fingers, reaching with hands and arms, talking and hearing. In some circumstances, bending, kneeling, crouching, stooping, and crawling may apply. This position may require lifting up to 15 pounds occasionally. Generally, work is performed in an office environment.
