Healthcare QA Specialist

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Job Description

Marken, a subsidiary of UPS Healthcare, boasts an impressive network of 128 locations and 5,500 dedicated employees worldwide. As a leader in Direct to Patient (DTP) and Home Health Care (HHC) services, we manage over 100,000 shipments of drug products and biological samples each month across more than 220 countries.

Position Overview

Are you a detail-oriented professional dedicated to quality and compliance? Marken is seeking a Quality Assurance Specialist to ensure the integrity of our Quality Management System (QMS) while adhering to regional regulations and customer requirements. In this role, youll navigate key regulatory frameworks, including Current Good Manufacturing Practice (GMP), Good Distribution Practices (GDP), and ISO standards.

Key Responsibilities

• Implementation and Maintenance of Quality Systems: Communicate and enforce compliance with Marken’s Global Quality Management System.
• Client Interaction: Engage with clients regarding Quality Assurance (QA) and GxP-related matters.
• Internal Stakeholder Collaboration: Collaborate with various Marken departments to support QA tasks.
• Internal Audit Management: Oversee internal audit schedules, conducting audits and preparing reports, including corrective and preventive actions (CAPA).
• External Audits and Vendor Selection: Audit external service providers and track commitments from previous audits.
• Client Audits and Regulatory Inspections: Host client audits, manage audit reports, and prepare necessary materials.
• CAPA Management: Develop CAPA plans, collate metrics, and implement quality improvement initiatives.
• Quality-Related Training: Identify training needs and coordinate quality-related training.
• Change Control Management: Oversee change control processes to ensure compliance.
• Record and Document Accuracy: Ensure accuracy and quality of all records and documentation.
• Training Monitoring: Manage training programs for personnel.
  
  

Skills And Experience

• Pharmaceutical, healthcare or food industry experience - Preferred
• Quality Assurance experience - Preferred
• Bachelor’s Degree in Science related field (or internationally comparable degree) required - Preferred
  
  

If you’re ready to join a team committed to delivering excellence in the pharmaceutical industry, we invite you to apply for the Quality Assurance Associate II position at Marken.

Employee Type

Permanent

UPS is committed to providing a workplace free of discrimination, harassment, and retaliation.

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