About the role

Australia Biotechnology Manufacturing is seeking a dedicated Quality Control/Assurance Officer to join our manufacturing operations in Keysborough, Victoria. This is a full-time position that plays a critical role in maintaining the highest standards of product quality and regulatory compliance across our biotechnology manufacturing facility. As a Quality Control/Assurance Officer, you will be responsible for ensuring that all products meet stringent quality specifications and that our operations adhere to relevant industry standards and regulations. This role is essential to our commitment to delivering safe, effective, and reliable biotechnology products to our customers.

Key responsibilities

• Conducting routine quality control testing and inspections on raw materials, in-process materials, and finished products in accordance with approved standard operating procedures

• Performing analytical testing using laboratory equipment and techniques to verify product specifications and detect any deviations or defects

• Performing environmental monitoring (EM) sampling — including viable and non-viable particulate, surface, personnel, and water sampling — across classified manufacturing areas in accordance with the approved EM program and standard operating procedures

• Supporting validation and qualification activities, including the cleaning validation, and process validation sampling, and the accurate documentation of results

• Compiling, trending, and analysing environmental monitoring data against established alert and action limits, identifying adverse trends, and preparing the Annual Product Quality Review (APQR)

• Documenting all quality control activities, results, and findings in a clear, accurate, and timely manner, maintaining comprehensive records for regulatory and audit purposes

• Investigating product non-conformances and deviations, identifying root causes and recommending corrective and preventative actions

• Collaborating with production and manufacturing teams to resolve quality issues and implement improvements

• Assisting with the development, validation, and maintenance of standard operating procedures and work instructions related to quality control activities

• Participating in internal audits and preparing documentation for external regulatory inspections and audits

• Supporting the continuous improvement of quality systems and processes to enhance efficiency and compliance

What we're looking for

• A diploma, degree, or equivalent qualification in chemistry, biochemistry, biotechnology, pharmaceutical science, or a related scientific discipline

• Proven experience working in a quality control or quality assurance role within a manufacturing, biotechnology, pharmaceutical, or related industry

• Experience in environmental monitoring, including water sampling and EM (viable and non-viable) sampling within a GMP environment

• Proficiency in performing laboratory testing and analytical procedures, with familiarity with standard laboratory equipment and instrumentation

• A solid understanding of quality management systems, Good Manufacturing Practice (GMP), and relevant regulatory frameworks

• Excellent attention to detail with the ability to follow procedures precisely and maintain accurate documentation

• Strong problem-solving skills with the ability to identify issues and implement appropriate solutions

• Excellent communication skills and the ability to work collaboratively with colleagues across different departments

• A commitment to maintaining a safe, compliant, and professional working environment

• Previous experience with GMP pharmaceutical products manufacturing is highly desirable

• Experience operating within classified clean-room environments is desirable
  

About us

Australia Biotechnology Manufacturing (ABM) is an Australian-owned company based in Melbourne’s southeast, specialising in the production of high-quality complementary medicines and health products. From our TGA-licensed, modern facility in Keysborough, we manufacture a range of products for both local and international markets.

At ABM, we’re proud of our reputation for quality and innovation. We offer a safe and supportive workplace where teamwork, respect, and accountability are valued, and where our people have the opportunity to learn, grow, and build rewarding careers.

Our Mission

To create a healthier future by producing trusted health and wellness products with care and quality at every step.

Our Vision

To be Australia’s most respected and innovative manufacturer of complementary medicines.

Where to find more information about us: https://abmpharma.com.au/

What we offer

We provide a competitive remuneration package and a range of benefits designed to support the wellbeing and development of our employees. Benefits include access to professional development opportunities, training programmes, and pathways for career advancement within our organisation. We are committed to fostering a supportive and inclusive workplace where all employees are respected and valued. If you require any adjustments or support during the recruitment process, we welcome your enquiry and will do our best to accommodate your needs.

Apply now

If you meet the above requirements and are interested in joining our team at Australia Biotechnology Manufacturing, please submit your application including your resume, cover letter, and contact details. We look forward to hearing from you.