Job title: Quality Associate

Location: Virginia, Brisbane.

You’ve built experience, now use it where bold ideas meet real impact. At Opella, we’re challenging how self-care works for millions of people and need leaders and experts ready to shape what’s next. As an [Experienced Hire Role], you’ll bring your skill, your curiosity and your drive to make health simpler, smarter and more human.

About the job

The Quality Associate reports directly to the Quality Systems and Technical Lead and is responsible for all quality assurance systems and qualification and validation activities for the Virginia manufacturing site.

This is a technical role and includes management of change controls, qualification, validation, computer systems validation, self-inspection and third-party management. Products manufactured in the Virginia site comprise both of listed and registered complementary medicines and a growth view for the manufacture of Over The Counter (OTC) products, with distribution both locally in Australia and within the Asia Pacific region.

Main Responsibilities

This is a highly collaborative role with key stakeholder management cross-functionality whilst assuring Quality in the areas of manufacturing, engineering, supply chain and Quality Control. Main responsibilities and accountabilities include:

Quality Compliance

• Manage and assist in the processing of Non-Conformances, Process Deviations, Corrective & Preventative Actions, Compliance Issues, Deletions & Quality Observations and associated documentation and filing of both physical and electronic documents, in line with Organisational, Regulatory and Environmental Standards.
• Manage and Drive Change control activities related to Validation and Calibration of new equipment and processes.
• Assist in the creation of new documentation and review existing documentation associated with equipment and processes within the facility.

Validation

• Manage the Site Validation Master Plan as required to ensure current alignment to regulatory and organisational requirements.
• Manage validation related activities to ensure, in accordance with the principles of cGMP, that the processes, equipment, cleaning methods, facilities, services, computer systems, spreadsheets & procedures employed within the operational facility will be able to consistently manufacture Complementary Medicinal products which achieve the relevant product specifications, in accordance with regulatory standards and organisational requirements.
• Manage the planning & reporting of all Virginia site validation and calibration activities e.g. Validation and Calibration of Equipment, Facilities, Services, HVAC, Processes, Cleaning, Computerised Systems, Spreadsheets.

Calibration

• Manage the Calibration Register and Calibration activities across the site.
• Schedule External Contractors to conduct calibrations when required.
• Technical Support
• Facilitate the cross-functional working relationships of the team by managing interactions between the team and key stakeholders including, External contractors, Operations, Engineering, Occupational Health & Safety, QC, ID&I and Regulatory Affairs.
• Assist in investigations, reviews, management and co-ordination of Quality Systems throughout the facility.
• Provide Technical advice and expertise with respect to Validation, Calibration and Quality Compliance. providing technical support to QS Specialists and users.

About you:

• Experience in pharmaceutical, complementary medicine, or OTC manufacturing within a GMP/cGMP-regulated environment.
• Strong knowledge of Quality Management Systems (QMS), including deviations, CAPA, non-conformances, change controls, and document control.
• Hands-on experience with validation and qualification activities (IQ/OQ/PQ, process validation, cleaning validation, HVAC, utilities, equipment).
• Knowledge of calibration management, maintenance coordination, and working with external contractors/vendors.
• Experience with Computer Systems Validation (CSV), spreadsheet validation, data integrity, and regulatory compliance (TGA/PIC/S GMP).
• Strong technical writing, root cause analysis, problem-solving, and audit/inspection readiness skills.
• Ability to collaborate cross-functionally with Manufacturing, Engineering, QC, Supply Chain, and Regulatory Affairs teams while managing multiple priorities.

This is more than the next step in your career, it’s a chance to lead change and help reinvent self-care for the world. If you’re ready to challenge, inspire and deliver impact that matters, we’re ready for you. We are challengers. We are Opella.