Quality Assurance Engineer

PSC Biotech® Corporation; City of Melbourne; On-site; AUD 90,000 - 130,000; Full time

Job summary

PSC Biotech Corporation in Melbourne is seeking a Quality Assurance Engineer on a 12‑month contract to provide QA oversight across commissioning, qualification, validation, tech transfer, process lifecycle, and vendor qualification.

You will ensure compliance with cGMP and global regulatory requirements, guide risk-based decisions with project teams, and participate in audits, continuous improvement, and supplier quality activities.

Qualifications

• Bachelor’s Degree in Engineering or Life Science.
• Minimum four years of experience in Quality Assurance, Validation, Manufacturing Quality, or Project Quality in regulated industries.
• Experience reviewing and approving GMP documentation (risk assessments, validation protocols, change controls, CAPAs).
• Experience supporting technology transfer, process validation, qualification, or capital projects.

Responsibilities

• Provide QA oversight for engineering, validation, manufacturing, and capital project activities.
• Review and approve GMP-related documents (validation protocols, qualification docs, risk assessments, CAPAs).
• Support commissioning, qualification, validation, technology transfer, and process lifecycle activities for regulatory compliance.

Skills

Quality & Compliance Excellence

Relationship Building

Problem Solving

Rational Persuasion

Interpersonal Awareness

Agility

Education

Bachelor’s Degree in Engineering or Life Science

Job description

We are looking for a Quality Assurance Engineer to join our team on a 12‑month contract. The role 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. The incumbent will maintain quality and compliance throughout the project lifecycle while supporting successful project execution and commercial operations, and will execute 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.

DEMOSTRATED COMPETENCIES

• Quality & Compliance Excellence – Strong understanding of cGMP, GxP principles, quality systems, validation lifecycle requirements, and global regulatory expectations.
• Relationship Building – Builds long‑term partnerships and connections across formal and informal professional and social networks in the life science industry.
• Problem Solving – Identifies, researches, and demonstrates logical reasoning to communicate critical information.
• Rational Persuasion – Utilizes active listening, presents key factors, and supports stakeholders in identifying solutions.
• Interpersonal Awareness – Recognizes how actions, ideas, and communication affect people and outcomes.
• Agility – Meets objectives by responding to competing priorities and multiple tasks under inflexible timelines.

REQUIRED EDUCATION AND WORK EXPERIENCE

• Bachelor’s Degree in Engineering or Life Science.
• Minimum four 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.