About us

Pharmako Biotechnologies is a leading Australian manufacturer of innovative nutraceutical, complementary medicine products. We are seeking a proactive Quality Assurance Associate to join our team. Located in a purpose built, TGA licensed facility on Sydney's Northern Beaches, we develop and manufacture products for customers across Australia and international markets.

We are seeking a proactive, highly organised and detail oriented Quality Assurance Associate to join our Quality team. In this hands on role you will report to the Quality Manager supporting daily quality operations, while working closely with Production, Warehouse, R&D; and Regulatory Affairs to ensure compliance with GMP, TGA and international quality standards

Qualifications and Experience

- Degree in Science, Pharmaceutical Science, Biotechnology, Microbiology, Chemistry, Food Science or a related discipline.

- Minimum 2 years' experience in a Quality Assurance or Quality Control role within a GMP-regulated environment.

- Working knowledge of GMP requirements, TGA regulations, PIC/S Guidelines and risk management principles.

- Experience within pharmaceutical, nutraceutical, complementary medicine or food manufacturing will be highly regarded.

- Experience with electronic quality management systems (eQMS) is advantageous.

- Environmental monitoring and audit experience is desirable.

- Knowledge of validation, change control and CAPA systems is preferred.

- Tasks & responsibilities

- Prepare, review, issue and reconcile Batch Manufacturing Records (BMRs).

- Prepare Bills of Materials (BOMs), dispensing records and supporting production documentation.

- Ensure raw materials, packaging components and intermediate materials are approved and released before production.

- Review manufacturing documentation for compliance with GMP requirements.

- Support batch disposition and document management activities.





- Perform line clearance inspections during manufacturing and packaging operations.

- Conduct In-Process Quality Control (IPQC) checks across powders, capsules, tablets, liquids and specialty delivery systems.

- Support GMP compliance across production and warehouse operations.

- Perform environmental monitoring activities and trend environmental data.

- Generate environmental monitoring reports and investigate adverse trends.

- Manage and investigate deviations, CAPAs, change controls and risk assessments.

- Assist with root cause investigations and implementation of corrective actions.

- Support Product Quality Reviews (PQRs), audits and regulatory inspections.

- Maintain document control systems including SOPs, specifications, forms and quality records.

- Contribute to continuous improvement initiatives that enhance quality systems and operational performance.

- Coordinate quality activities across departments to support production schedules and customer requirements.

Essential Skills

- High attention to detail and robust organisational skills.

- Strong technical writing, documentation and record management capabilities.

- Excellent verbal and written communication skills.

- Ability to manage multiple priorities in a fast paced manufacturing environment.

- Proficiency in Microsoft Word, Excel and related software applications.

- A proactive, solutions focused approach to problem solving.

- Ability to work both independently and collaboratively within a cross functional team.

- Strong commitment to quality, compliance and continuous improvement.

- Positive attitude, strong work ethic and a desire to contribute to a growing business.

Pharmako offers the opportunity to join an innovative manufacturing organisation, gain exposure to a diverse range of nutraceutical products, and develop your career within a supportive and collaborative team environment. To be a successful candidate for this role you will need to be highly motivated and organised, and an excellent communicator with a goal for achieving results.

📌 Quality Assurance Associate (Frenchs Forest)
🏢 Pharmako Biotechnologies
📍 Frenchs Forest