Sr. Spclst, External Quality

Job Description
Senior Specialist, External Manufacturing Quality (Contract Role)
THE OPPORTUNITY

• Based in Australia or New Zealand, join a global healthcare biopharma company and be part of 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 in supplying finished products that comply with AH specifications and local country regulatory requirements.

Our Quality Assurance
group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers

we create an interdependent global manufacturing network committed to deliver 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 and have a deep sense of responsibility towards our customers, consumers, animals, society and our planet. We offer one of our industry's most innovative portfolio of products, services and technologies that serve to 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 that the transfer is successful and is completed in compliance to international and local GMP requirements and the requirements of AH Quality Manual or other internal agreed standards.

What Will You Do In This Role

• Timely review and provide expert inputs 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 and finished product batch records; Stability protocols and reports.
• Act as AH Quality Operations point of contact between the CMO and the internal AH personnel in term of the quality requirements for Technical Product Transfers between CMOs in the specific region.
• Review and approve all required Technical Transfer documentation in support of Product Transfers. Travel may be required to the CMOs.
• Review all Deviation investigations submitted by the CMOs and supports 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

• Bachelor's degree in Veterinary, Chemistry, Pharmacy, Biology, Microbiology, Chemical Engineering (or equivalent), preferably with experience in in Quality Systems, Quality Assurance and Quality Control including solid knowledge of global GMP and regulatory requirements
• Must have experience of Product Technical Transfer and Analytical Method Transfer
• Must have excellent problem-solving skills, based on science, facts, data and understanding of the regulatory requirements in complex and evolving environments; must be able to apply sound risk management techniques e.g. HACCP, FMEA
• Must have expertise in interdisciplinary areas of pharmaceutical sciences, analytical chemistry, microbiology, sterile operations, GMPs and regulatory issues

Who We Are
We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and our company everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What We Look For
Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

Required Skills
Accountability, 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 {+ 4 more}

Preferred Skills
Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status
Temporary (Fixed Term)

Relocation
VISA Sponsorship
Travel Requirements
Flexible Work Arrangements
Hybrid

Shift
Valid Driving License
Hazardous Material(s)
Job Posting End Date
12/16/2025

• A job posting is effective until PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID
R373224