Quality Assurance Engineer

biotech; City of Melbourne; On-site; AUD 90,000 - 120,000; Full time

Job summary

biotech is seeking a Quality Assurance Engineer for a 12-month contract in Melbourne to provide QA oversight across commissioning, qualification, validation, technology transfer and process lifecycle activities.

The role ensures compliance with regulatory requirements, maintains product integrity, and supports successful project execution and commercial operations. A Bachelor’s degree in engineering or life sciences with 4+ years in QA/validation is required.

Qualifications

• Bachelor’s Degree in Engineering or Life Science required; minimum 4 years in QA/validation within regulated industries.
• Experience reviewing and approving GMP documentation including risk assessments, validation protocols, qualification documents, change controls, deviations, and CAPAs.
• Strong knowledge of cGMP, GxP, and international regulatory requirements; strong technical writing and document review skills.

Responsibilities

• Provide QA oversight for engineering, validation, manufacturing, and capital project activities.
• Review and approve GMP-related documents, including validation protocols, qualification documents, risk assessments, and CAPA records.
• Support commissioning, qualification, validation, technology transfer, and process lifecycle activities to ensure regulatory compliance.
• Facilitate and support quality systems including deviations, investigations, change controls, CAPA, and risk management.

Skills

Quality Assurance

GxP knowledge

GMP documentation

Regulatory compliance

Risk assessment

Technical writing

Education

Bachelor's Degree in Engineering or Life Science

Job description

POSITION SUMMARY:

We are looking for a Quality Assurance Engineer to join our team on a 12-month contract. The Quality Assurance Engineer is responsible for providing Quality Assurance oversight and support for commissioning, qualification, validation, technology transfer, process lifecycle management, capital projects, vendor qualification, and operational quality activities. This role is accountable for maintaining quality and compliance throughout the project lifecycle while supporting successful project execution and commercial operations. The incumbent is also responsible and accountable for the execution of the PSC mission, “to maintain the integrity and professionalism of our products and services while enabling steady growth and development”.

DUTIES AND RESPONSIBILITIES:

• Provide Quality Assurance oversight for engineering, validation, manufacturing, and capital project activities.


• Review and approve GMP-related documents, including validation protocols, qualification documents, risk assessments, technical transfer documentation, and quality system records.


• Support commissioning, qualification, validation, technology transfer, and process lifecycle activities to ensure compliance with regulatory and company requirements.


• Facilitate and support quality systems including deviations, investigations, change controls, CAPA, and risk management activities.


• Ensure compliance with cGMP, GxP, site procedures, and applicable global regulatory requirements.


• Provide quality guidance and risk-based decision-making to project teams and operational stakeholders.


• Collaborate with Engineering, Manufacturing, Validation, Quality Control, Supply Chain, and Regulatory teams to achieve project and business objectives.


• Participate in audits, inspections, and continuous improvement initiatives to maintain and enhance compliance and quality performance.


• Support vendor qualification and supplier quality activities as required.


• Additional duties and responsibilities may be assigned from time to time.

DEMONSTRATED COMPETENCIES:

Quality & Compliance Excellence – Strong understanding of cGMP, GxP principles, quality systems, validation lifecycle requirements, and global regulatory expectations. Relationship Building – Works with and across formal and informal professional and social networks to build long-term partnerships and connections in the life science industry. Problem solving – Identifies, researches, and demonstrates logical reasoning to communicate critical information. Rational Persuasion –, Active listening, Presents key factors influencing factors, and strategic goals to assist stakeholders in identifying solutions. Interpersonal Awareness – Ability to be aware of how actions, ideas, and communication can/does affect people and their outcomes. Agility – Meets objectives by responding to competing and changing priorities and multiple tasks under inflexible timelines.

REQUIRED EDUCATION AND WORK EXPERIENCE:

Bachelor’s Degree in Engineering or Life Science. Minimum 4 years of experience in Quality Assurance, Validation, , Manufacturing Quality, or Project Quality within the pharmaceutical, biotechnology, medical device, or other regulated industries. Demonstrated experience reviewing and approving GMP documentation including risk assessments, validation protocols, qualification documents, change controls, deviations, and CAPAs. Experience supporting technology transfer, process validation, qualification, engineering, manufacturing, or capital projects. Working knowledge of cGMP, GxP, FDA, EMA, TGA, PIC/S, and international regulatory requirements. Strong technical writing and document review skills. Ability to build and maintain relationships with stakeholders across multiple functions and organizational levels.