Quality Assurance Specialist

Pscbiotech; Brisbane; On-site; AUD 110,000 - 135,000; Full time

Job summary

PSC Biotech is seeking a Quality Assurance Specialist in Brisbane for a 6-month contract. You will oversee QA activities across commissioning, validation, technology transfer, and lifecycle processes, ensuring adherence to cGMP and global regulatory standards.

Responsibilities include reviewing GMP documents, supporting audits, handling deviations and CAPAs, and collaborating with cross-functional teams to drive compliant project execution.

Qualifications

• Bachelor’s Degree in Engineering or Life Science.
• Minimum 2 years of experience in Quality Assurance, Validation, Manufacturing Quality, or Project Quality within regulated industries.
• 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.

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 regulatory compliance.
• Facilitate and support quality systems including deviations, investigations, change controls, CAPA, and risk management.
• 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 objectives.
• Participate in audits, inspections, and continuous improvement initiatives to maintain and enhance compliance and quality.
• Support vendor qualification and supplier quality activities as required.
• Additional duties may be assigned from time to time.

Skills

Quality assurance

Regulatory knowledge

Technical writing

Stakeholder collaboration

Education

Bachelor’s Degree in Engineering or Life Science

Job description

Brisbane, Australia | Posted on 09/22/2026

We are looking for a Quality Assurance Specialist to join our team on a 6-month contract. The Quality Assurance Specialist is responsible forproviding 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 theproject lifecycle while supporting successful project execution and commercialoperations. The incumbent is also responsible andaccountable for the execution of the PSC mission, “to maintain the integrityand professionalism of our products and services while enabling steady growthand development”.

D U T I E S A N D R Es P O N SIBI L IT IE S :

• Provide Quality Assurance oversight forengineering, 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 ensurecompliance with regulatory and company requirements.
• Facilitate and support quality systemsincluding deviations, investigations, change controls, CAPA, and riskmanagement activities.
• Ensure compliance with cGMP, GxP, siteprocedures, and applicable global regulatory requirements.
• Provide quality guidance and risk-baseddecision-making to project teams and operational stakeholders.
• Collaborate with Engineering, Manufacturing,Validation, Quality Control, Supply Chain, and Regulatory teams to achieveproject and business objectives.
• Participate in audits, inspections, andcontinuous improvement initiatives to maintain and enhance compliance andquality performance.
• Support vendor qualification and supplierquality activities as required.
• Additional duties and responsibilities may beassigned from time to time.

DE M O N S TR A T E D C O M P E T E N CI ES :

• Quality &Compliance Excellence – Strongunderstanding of cGMP, GxP principles, quality systems, validation lifecyclerequirements, and global regulatory expectations.
• Relationship Building – Works with and acrossformal and informal professional and social networks to build long-termpartnerships and connections in the life science industry.
• Problem solving –Identifies, researches, and demonstrates logical reasoning to communicatecritical information.
• Rational Persuasion –, Active listening, Presents key factors influencing factors, andstrategic goals to assist stakeholders in identifying solutions.
• Interpersonal Awareness – Ability to be aware ofhow actions, ideas, and communication can/does affect people and theiroutcomes.
• Agility – Meets objectives by responding to competingand changing priorities and multiple tasks under inflexible timelines.

Requirements

R E QU I R E D E D UC A TI O N A N D W O RK E X P E R I E N C E :

• Bachelor’s Degree in Engineeringor Life Science.
• Minimum 2 yearsof experience in Quality Assurance, Validation, Manufacturing Quality, orProject Quality within the pharmaceutical, biotechnology, medical device, orother regulated industries.
• Demonstratedexperience reviewing and approving GMP documentation including riskassessments, validation protocols, qualification documents, change controls,deviations, and CAPAs.
• Experiencesupporting technology transfer, process validation, qualification, engineering,manufacturing, or capital projects.
• Working knowledge of cGMP, GxP, FDA, EMA, TGA, PIC/S, andinternational regulatory requirements.
• Strong technical writing and document review skills.
• Ability tobuild and maintain relationships with stakeholders across multiple functionsand organizational levels.