Senior QA Officer

Job Description

Senior QA Officer

• Permanent full-time rolewith competitive remuneration and benefits

• Location: Wellington - Upper Hutt New Zealand

• Career growth:Expand your expertise in a growing successful industry

• Professional development:Gain valuable experience in a dynamic evolving role

The Senior QA Officer plays a key role within the Quality Assurance Batch Release Team supporting QA Officers to ensure batch documentation is prepared reviewed and product is released on schedule. Reporting to the Supervisor - QA Batch Release this role is responsible for maintaining QA systems supporting compliance and helping ensure the smooth running of the QA department in line with regulatory and corporate standards.

This position offers the opportunity to contribute across batch release deviation management change control auditing continuous improvement and quality system compliance in a regulated production environment.

What You Will Do

Responsibilities include however not limited to:

• Support the preparation review and release of batch documentation to meet production and testing schedules

• Issue batch documents and test worksheets allocate expiry dates and complete SAP transactions

• Monitor departmental KPIs and support action plans to address trends in conjunction with the Quality Assurance Manager

• Contribute to continuous improvement across QA systems such as batch review document control and archiving GMP training systems internal auditing change control deviation management and right-first-time programs

• Review batch and test documentation for accuracy completeness and compliance

• Facilitate correction or completion of documentation with colleagues across other departments

• Reconcile documentation to support effective document control

• Ensure batch release documentation is available to meet export schedules

• Generate and maintain documentation in accordance with company and relevant quality standards

• Maintain production-related batch and inventory records in accordance with company and relevant quality standards

• Define processes and support improvements through updated standards and training

• Follow global and local procedures for reporting adverse events and product quality complaints

• Review and approve closure of deviations including root cause analysis corrective and preventive actions compliance risk assessment and product disposition recommendations

• Act as a quality representative for nominated site changes and corrective and preventive actions

• Complete assigned internal and external GMP audits and author audit reports

• Author or technically review SOPs for new processes

• Coach colleagues in other departments to improve documentation standards and compliance with QA systems

• Author reports and protocols such as stability and annual product review reports

• Perform QA review and approve validation protocols and reports

• Complete gap analyses of local procedures against corporate requirements

• Develop and implement efficient systems to support regulatory and corporate compliance

• Analyse system trends and KPIs and develop action plans to address weaknesses

What You Must have

• Bachelors degree or higher in a science-based discipline

• Understanding of Quality Assurance systems and Good Laboratory Practice and Good Manufacturing Practice requirements in a production environment

• Prior experience in a similar role within a GMP or GLP manufacturing environment ideally in pharmaceutical quality operations

• Demonstrated experience across more than one biopharmaceutical operation such as manufacturing technology validation engineering quality or analytical

• Strong written and verbal communication skills with the ability to positively influence others

• Ability to work collaboratively to solve complex problems and issues

• Demonstrated leadership skills and the ability to build effective working relationships with key stakeholders

• Sound and logical problem-solving ability

• Ability to plan and manage your work schedule to meet deadlines

• Qualified Lead Auditor desirable

What You Can Expect

• A key quality role supporting batch release and compliance in a regulated manufacturing environment

• Exposure across QA systems audits deviations change control and continuous improvement

• The opportunity to influence quality outcomes and help drive right-first-time performance

• A collaborative environment where your technical expertise and leadership are valued

• Scope to grow your capability across multiple quality disciplines within a high-performing team

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 anothers thinking and approach problems collectively. We are an equal opportunity employer committed to fostering an inclusive workplace.

Required Skills:

Batch Record Review Biopharmaceutical Industry Corrective and Preventive Action (CAPA) Creating Action Plans Document Control Systems Gap Analysis GMP Compliance Good Manufacturing Practices (GMP) Laboratory Information Management System (LIMS) Quality Assurance (QA) Quality Auditing Quality Improvement Programs Quality Management Systems (QMS) Regulatory Compliance Statistical Process Control (SPC) Training and Development

Preferred Skills:

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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:

No relocation

VISA Sponsorship:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Not Applicable

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

N/A

Job Posting End Date:

08/29/2026

*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.