Sr. Spclst, External Quality

Senior Specialist, External Manufacturing Quality (Contract Role)

Based in Australia or New Zealand, join a global healthcare biopharma company with a 130‑year legacy of success backed by ethical integrity, forward momentum and an inspiring mission to achieve new milestones in global healthcare.

The QA Senior Specialist – External Manufacturing Quality (Animal Health) will support Contract Manufacturing Organizations (CMOs) in Australia and / or New Zealand to supply finished products that comply with AH specifications and local country regulatory requirements.

The Opportunity

Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed in alignment with our high standards of quality and meets all regulatory requirements. We partner with internal manufacturing facilities, external contract manufacturers and suppliers to create a global manufacturing network committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.

Animal Health Division

Our Animal Health division is a trusted global leader in veterinary medicine, dedicated to the health and well‑being of animals. We are a global team of professionals working together to make a positive difference in animal care and the world’s food supply. We offer an innovative portfolio of products, services and technologies that prevent, treat and control diseases across all major farm and companion animal species.

The incumbent is responsible for supporting Technical Product Transfer from one CMO to another to ensure the transfer is successful and completed in compliance with international and local GMP requirements, the AH Quality Manual, and other agreed internal standards.

What Will You Do In This Role

• Review and provide expert input and / or comments into documents and reports, such as Raw material specifications, Packaging material specifications, Test methods, Validation / qualification protocols and reports, Master batch documentation, finished product batch records, Stability protocols and reports.
• Act as AH Quality Operations point of contact between the CMO and internal AH personnel regarding quality requirements for Technical Product Transfers between CMOs in the region.
• Review and approve all required Technical Transfer documentation in support of Product Transfers. Travel to the CMOs may be required.
• Review all Deviation investigations submitted by the CMOs and support further investigation where necessary.
• Contribute to cross‑functional investigations and project teams.
• Review batch documentation and data to support batch release activities when appropriate.

What Should You Have

Who We Are

We are known as Merck & Co., Inc., based in Rahway, New Jersey, USA, but our company operates worldwide.

What We Look For

Imagine starting each day with an opportunity to help save and improve lives around the world. Join us and bring your empathy, creativity, digital mastery or scientific genius to collaborate with a diverse team pursuing hope and innovation.

Required Skills

Accountability, Adaptability, Analytical Chemistry, Batch Releases, Bioanalysis, Corrective Action Management, Data Analysis, Deviation Management, External Manufacturing, GMP Compliance, Interpersonal Relationships, IS Audit, Legal Compliance, Manufacturing, Manufacturing Quality Control, Metrics Reporting, Microbiology, Molecular Microbiology, Pharmaceutical Quality Assurance, Pharmaceutical Sciences, Product Quality Complaints, Product Quality Control, Quality Assurance (QA), Quality Improvement.

Employee Status

Temporary (Fixed Term)

Travel Requirements

Travel may be required to CMOs.

Flexible Work Arrangements

Hybrid

Job Posting End Date

12 / 16 / 2025

Requisition ID

#J-18808-Ljbffr