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Junior Commercial Quality Professional

Position Summary

The Junior Commercial Quality Professional supports the execution and maintenance of the Product Quality Complaint (PQC) management process for Johnson & Johnson Innovative Medicine across Australia and New Zealand.

Working under the guidance of CQ Head/Associate CQ manager, this role assists in ensuring compliance with J&J Quality Policies, procedural documents, and applicable regulatory requirements. The incumbent supports complaint management activities, documentation, reporting, and quality system processes while developing knowledge of quality and regulatory requirements within the pharmaceutical industry.

The Junior Commercial Quality Professional consistently demonstrates J&J's Credo values and Leadership Imperatives while building effective partnerships with internal and external stakeholders.

Responsibilities

Product Quality Complaint Management

• Support the receipt, review, logging, and processing of Product Quality Complaints in accordance with regulatory requirements and local and global procedures.
• Prepare and issue complaint acknowledgements and close-out communications under guidance.
• Follow up with customers and internal stakeholders to collect complaint information and supporting documentation.
• Escalate potential compliance risks or significant quality issues to senior Commercial Quality personnel.
• Support the preparation of responses to inquiries from Health Authorities and internal stakeholders.

Stability Assessments

• Support the assessment of products involved in temperature excursions using established procedures and approved tools.
• Assist with documentation of assessments and communication of outcomes to relevant stakeholders.

Complaint Sample Management

• Coordinate retrieval of complaint samples and required documentation from customers.
• Arrange shipment of complaint samples or photographs to manufacturers for investigation.
• Maintain accurate records of sample management activities.

Reconciliation Activities

• Participate in routine reconciliation activities in accordance with local and global procedures.
• Support identification and resolution of discrepancies under supervision.

Documentation, Filing and Archiving

• Maintain compliant filing and archiving systems for quality records and complaint documentation.
• Ensure accurate and timely filing of source documents in accordance with company requirements.

Procedural Documents and Training

• Support the maintenance and periodic review of local procedural documents, work instructions, and training materials.
• Participate in training activities and complete assigned training requirements within required timelines.
• Assist with the delivery of awareness sessions and training when appropriate.

Quality Reporting and Continuous Improvement

• Support the preparation of routine quality metrics, reports, and presentations.
• Assist in identifying trends and opportunities for process improvement.
• Participate in local, regional, or global quality initiatives as assigned.

Audit and Inspection Support

• Support preparation for internal audits, external audits, and Health Authority inspections.
• Assist with the collection and organization of documentation required during audits and inspections.
• Contribute to implementation of corrective actions arising from audit observations, under guidance.

Additional Responsibilities

• Support other Commercial Quality activities and projects as assigned by the supervisor.
• Develop knowledge of J&J quality systems, regulatory requirements, and industry best practices.

Required Skills and Qualifications

• Bachelor's degree in Pharmacy, Life Sciences, Biomedical Sciences, Medical Sciences, or a related discipline.
• Strong written and verbal communication skills.
• Good attention to detail and organizational skills.
• Ability to manage multiple tasks and priorities.
• Proficiency in Microsoft Office applications and willingness to learn quality management systems and databases.
• Ability to work collaboratively within cross-functional teams.

Preferred Experience

• Experience in Quality, Customer Service, Regulatory Affairs, Supply Chain, Healthcare, Pharmaceutical, Medical Device, or related environments.
• Exposure to pharmaceutical, healthcare, life sciences, or medical device industries is desirable.

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