Quality Associate

About the role

Opella is seeking a Quality Associate to join its Virginia site in Brisbane on a 12‑month fixed‑term contract. Reporting to the Quality Compliance Lead, you will ensure that manufacturing operations meet cGMP standards, manage batch release, and handle deviations and product complaints.

Key responsibilities

• Oversee batch release, operational quality, deviations and complaints management.
• Review and approve batch‑related documentation such as manufacturing formulas, instructions and specifications.
• Ensure production processes are audit‑ready and performed in accordance with cGMP and standard operating procedures.
• Monitor and communicate quality KPI metrics through department meetings and quality reviews.
• Act as the first point of contact for any issue that may affect product quality or safety.
• Identify continuous‑improvement opportunities, risks and cGMP deficiencies, and work with Production and Engineering to implement corrective actions.
• Close non‑significant deviations promptly and support investigations to meet agreed timelines.
• Manage product technical complaints and conduct investigations.
• Participate in internal and regulatory audits and ensure readiness for customer audits.
• Review and audit batch records according to established procedures.

Required profile

• Experience in quality assurance within a regulated manufacturing environment.
• Strong knowledge of cGMP requirements and SOP compliance.
• Ability to work collaboratively across manufacturing, engineering, supply chain and quality functions.
• Proactive mindset for continuous improvement and risk identification.
• Effective communication skills for stakeholder management and audit preparation.

Required skills

• cGMP compliance
• Batch record review
• Deviation management
• Product complaint investigation
• Quality KPI monitoring

What we offer

• Opportunity to contribute to the launch of OTC and complementary medicines.
• Collaborative, cross‑functional work environment.
• 12‑month fixed‑term contract with potential for extension.