Quality Assurance Officer

Merck Merck · Pharma · Wellington, New Zealand

This role is for a Quality Assurance Officer at Merck, focused on ensuring batch documentation is prepared, reviewed, and released on schedule to meet production, testing, and export requirements. It involves supporting QA systems, maintaining compliance with regulatory and corporate standards (GMP/GLP), and facilitating product release.

What you'd actually do

  1. Issuing batch documents and test worksheets and completing required SAP transactions
  2. Monitoring department KPIs and, in conjunction with the Quality Assurance Manager, implementing action plans to address trends
  3. Supporting continuous improvement by contributing to QA systems where trained (for example: batch review, document control and archiving, GMP training systems, internal auditing, change control, deviation management, Right First-Time programs)
  4. Reviewing batch and test documentation for accuracy, completeness, and regulatory compliance
  5. Facilitating correction or completion of documentation with colleagues in other departments and reconciling records to maintain effective document control

Skills

Required

  • Bachelor’s degree or higher in a science-based discipline
  • Knowledge of Quality Assurance (QA) systems and Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) requirements in a production environment
  • Demonstrated experience across multiple biopharmaceutical functions (for example, manufacturing, technology, validation, engineering, quality, analytical)
  • Excellent written and verbal communication skills, with the ability to positively influence others
  • Proven ability to work collaboratively in a team to resolve complex problems and issues
  • Sound, logical approach to problem solving
  • Strong time-management skills with the ability to plan work and meet deadlines
  • Analytical Problem Solving
  • Batch Record Review
  • Detail-Oriented
  • Good Manufacturing Practices (GMP)
  • Manufacturing Environments
  • Quality Assurance (QA)
  • Quality Assurance (QA) Standards
  • Quality Assurance Systems

Nice to have

  • Prior experience in a similar role within a GMP/GLP manufacturing environment is desirable - preferably in the pharmaceutical industry in Quality Operations or a comparable manufacturing role
  • Demonstrated leadership skills and the ability to build effective working relationships and align with key stakeholders across the business

What the JD emphasized

  • GMP
  • GLP
  • regulatory compliance