Job Description
Quality Assurance - Lead Technician (FPU/FPP Release)
Permanent, full-time role with competitive remuneration and benefits
Location: Wellington - Upper Hutt, New Zealand
Grow your QA leadership career in a successful, expanding industry
Lead critical QA activities for FPU/FPP release in a global Animal Health manufacturer
Be the go-to expert for batch documentation, product release and continuous improvement
What You Will Do
Responsibilities include, however not limited to:
You will play a key role in batch documentation, product release, and quality systems, helping ensure timely supply of high-quality products.
Batch Documentation
Ensure batch documentation is available and compliant to meet production and testing schedules by:
Providing backup for QA / Senior QA Officers in issuing batch documents and test worksheets, allocating expiry dates, and completing SAP transactions
Monitoring department KPIs and supporting action plans with the Quality Assurance Manager
Driving continuous improvement by providing subject matter expertise in QA systems such as:
Batch review and disposition
Document control and archiving
GMP training systems
Internal auditing
Change control and deviation management
Right First-Time and other quality improvement programs
Product Release
Support timely and compliant product release by:
Providing backup for QA / Senior QA Officers in reviewing batch/test documentation for accuracy, completeness and compliance, and facilitating corrections with other departments
Performing second quality review of Solution, Antigen, Bulk Antigen and Blend batch records
Releasing Antigen, Blend and packed product batch records
Reviewing and approving market documents for export and ensuring release documentation meets export schedules
Providing batch disposition for temperature excursions
Approving revalidations of Antigens and Pack-at-Risk
General Documentation & Compliance
Generate, review and maintain all documentation in line with company and relevant quality standards
Ensure all production-related batch and inventory records are accurate and complete
Define processes and drive improvements through updated standards and training
Follow global and local procedures for reporting Adverse Events and Product Quality Complaints within required timelines
Deviations & Change Management
Review and approve deviation closures, including supporting documentation
Use root cause analysis to define appropriate Corrective and Preventative Actions (CAPAs)
Assess compliance risks for impacted products and recommend product disposition
Approve events following completed batch disposition
What You Must have
Education
Certifications
Experience & Skills
Strong understanding of QA systems, GLP and GMP requirements in a production environment
Extensive prior experience in a similar role in a GMP/GLP manufacturing environment, ideally in the pharmaceutical industry within Quality Operations or similar manufacturing role
Demonstrated experience in more than one biopharmaceutical function (e.g. manufacturing, technology, validation, engineering, quality, analytical)
Excellent written and verbal communication skills with the ability to positively influence others
Proven ability to work collaboratively to resolve complex problems
Demonstrated leadership and ability to build strong relationships and alignment with key stakeholders
Logical, structured approach to problem solving
Strong planning and organisational skills, with the ability to meet deadlines
What You Can Expect
A pivotal QA role where your decisions directly support safe, reliable product supply
Autonomy to manage your work, with strong support from a trusted, global-leading Animal Health organisation
Clear opportunities to upskill, cross-train and progress your QA career
Exposure to quality systems and projects that broaden your technical and leadership capabilities
A collaborative team of experienced QA and Operations professionals who value knowledge sharing and continuous improvement
We are proud to be a company that embraces the value of bringing talented and committed people together. The fastest way to breakthrough innovation is when ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive workplace.
Required Skills:
Batch Record Review, Batch Releases, Compliance Risk Management, Corrective and Preventive Action (CAPA), Driving Continuous Improvement, GMP Compliance, Good Manufacturing Practices (GMP), Lean Manufacturing, Legal Compliance, Quality Assurance (QA), Quality Process Development, Supplier Quality Management
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:
Regular
Relocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Not Applicable
Shift:
Valid Driving License:
Hazardous Material(s):
Job Posting End Date:
03/21/2026
*A job posting is effective until 11:59:59PM 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:R381496
