Together, we are Marken, UPS Healthcare Precision Logistics. As the clinical and advanced therapy part of UPS Healthcare, we reach patients faster, with greater scalability and access to new pathways throughout the supply chain. With our One UPS advantage and comprehensive service portfolio, including Polar Speed's in-network pharmacies, we are optimally positioned to keep our clients competitive in an increasingly complex market.
Main Purpose
The Quality Assurance Specialist Auditor (QA) is responsible for managing and performing vendor qualifications and supporting client and regulatory audits as required. The QA will be responsible for vendor onboarding, prepare audit reports, address CAPAs, and track audit responses to ensure GxP compliance. This temporary role is part of the MNX integration project and focuses on onboarding MNX vendors in accordance with Marken, GDP and other applicable requirements. The position requires cross-functional collaboration with all Marken PL service lines.
Temporary Position - 12 month assignment
Main Duties and Responsibilities
Maintain compliance with Marken's PL Global Quality Management System and local regulatory requirements Collaborate with Marken PL departments and stakeholders to support quality initiatives and continuous improvement. Manage the vendor qualification program, including performing audits, updating Quality Technical Agreements (QTAs), and ensuring compliance with GxP, regional/local regulations, and Marken PL business requirements. Prepare audit reports and track corrective actions (CAPAs) to closure. Conduct vendor risk assessments based on audit findings and business impact, and escalate high-risk issues as needed. Ensure vendor documentation meets data integrity standards and other applicable industrial standards Monitor regional vendor management activities and ensure alignment with the global vendor management program. Work with vendors to manage changes and implement quality improvements related to services provided. Manage and approve change controls and deviations submitted by or related to Marken vendors/suppliers.
General
Ensure compliance with national and international standards and legislation Adhere to Good Manufacturing / Distribution / Clinical Practices. Effectively interact with Global and Regional Quality Assurance personnel, Quality Managers, Branch / Operations / Depot Managers, and stakeholders to maintain quality. Support Marken's culture of continuous improvement by introducing new quality advances. Ensure timely and efficient management of records pertaining to the Quality Assurance. To support daily tasks and issues as needed Travel as reasonably requested for the performance of duties. To adhere to all company Policies at all times. To undertake any other reasonable duties at the request of the Line Manager. ASQ or ISO Certification preferred
Acknowledgement
By signing in ZenQMS the jobholder agrees to comply with the requirements of the job description, and understands that failure to comply with the requirements may result in disciplinary action.
By signing in ZenQMS the line manager confirms the job description is a true and accurate reflection of the duties and responsibilities of the role, which has been fully explained to- and understood by- the jobholder.
Any changes to the job description must be agreed by the line manager and the jobholder.
Employee Type:
Permanent
UPS is committed to providing a workplace free of discrimination, harassment, and retaliation.
Other Criteria:
UPS is an equal opportunity employer. UPS does not discriminate on the basis of race/color/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity or any other characteristic protected by law.
Basic Qualifications:
Must be a U.S. Citizen or National of the U.S., an alien lawfully admitted for permanent residence, or an alien authorized to work in the U.S. for this employer.
QA Associate - Temp 12 month assignment • Philadelphia, PA, United States
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