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Quality assurance associate – pharmaceutical cdmo

Gold Coast
Epsilon Pharma
Biostatistician
Posted: 1 May
Offer description

About Us

Epsilon Pharma Pty Ltd is part of Epsilon Healthcare. Epsilon Healthcare Limited (ASX: EPN) is an Australian based, globally active healthcare organisation. With a diversified and vertically integrated portfolio of assets, including healthcare, pharmaceutical contract development and manufacture, pharmacy services & biotechnology, EPN is well placed to support patient, and client needs, to capitalise on current and emerging markets within the medical and wellness space.

At Epsilon Pharma we are a fast-growing Contract Development and Manufacturing Organisation (CDMO) specialising in pharmaceutical products, located in the heart of the beautiful Gold Coast, Queensland. With cutting-edge facilities and a client focused approach, we support local and international partners in the development, manufacture, and supply of high quality pharmaceutical products.

As we continue to diversify our operations and expand our capabilities and client portfolio, we are seeking a dynamic a detail-oriented Quality Assurance Associate to support and maintain our quality systems, ensuring compliance with TGA and international pharmaceutical standards.

Key Responsibilities:

About the Role

Reporting to the Director of Quality, Epsilon Pharma, the Quality Assurance Associate will play an integral role in supporting and maintaining our quality systems, ensuring compliance with TGA and international pharmaceutical standards. This is an important role role within our business, with direct influence on the provision of a high quality service delivering customer satisfaction, sustainability and long term growth.

Key Responsibilities

· Ensure compliance with regulatory requirements, including GMP and PIC/S guidelines

· Maintain and manage quality documentation, records, and procedures

· Conduct internal audits and support validation activities

· Issue batch records to production and support product release activities

· Perform environmental monitoring of manufacturing areas

· Investigate deviations, non-conformances, and customer complaints

· Support CAPA, change control, and vendor assurance processes

· Order and manage artwork, and review product label compliance to ensure regulatory accuracy

· Contributing to the integration and operationalisation of an enterprise of eQMS

· Collaborate with internal teams and contractors to uphold quality standards

About You

We are looking for a results detail focused quality professional with a strong background in pharmaceutical or related regulated manufacturing environments.

Essential Skills & Experience:

· Tertiary qualification or relevant experience in pharmaceuticals or a similar field

· Experience in product release within a regulated environment

· Strong understanding of quality systems and regulatory requirements

· Excellent attention to detail and organisational skills

· Effective communication and teamwork abilities

· Proficient in Microsoft Office and able to learn new systems quickly

· Able to manage multiple tasks and work under pressure

· Commitment to safety, compliance, and ethical standards

Why Join Us?

· Competitive salary package + super

· Opportunity to make a meaningful contribution towards shaping the future of a growing pharmaceutical company

· Work in a purpose driven, collaborative team environment

· Lifestyle location – work where others holiday!

How to Apply

Formal applications, including two available referees who may be contacted for the above position, should be forwarded no later than Friday 23rd May 2026 to

***********@epsilonpharma.com.au

Only shortlisted applicants will be contacted

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