QA Associate - Temp 12 month assignment

UPS

About The Position

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 assigment

Requirements

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.

Nice To Haves

ASQ or ISO Certification preferred

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.
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.