Job Description

POSITION SUMMARY :

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We are looking for a Quality Assurance Specialist to join our team on a 6-month contract. The Quality Assurance Specialist is responsible for
n providing Quality Assurance oversight and support for commissioning,
n qualification, validation, technology transfer, process lifecycle management,
n capital projects, vendor qualification, and operational quality activities.
n This role is accountable for maintaining quality and compliance throughout the
n project lifecycle while supporting successful project execution and commercial
n operations. The incumbent is also responsible and
n accountable for the execution of the PSC mission, “to maintain the integrity
n and professionalism of our products and services while enabling steady growth
n and development”.

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DUTIES AND RESPONSIBILITIES:

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

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

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

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

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- Ensure compliance with cGMP, GxP, site
n procedures,



and applicable global regulatory requirements.

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

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

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

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- Support vendor qualification and supplier
n quality activities as required.

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- Additional duties and responsibilities may be
n assigned from time to time.

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DEMONSTRATED COMPETENCIES:

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- Quality &
n Compliance Excellence – Solid
n understanding of cGMP, GxP principles, quality systems, validation lifecycle
n requirements, and global regulatory expectations.

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- Relationship Building – Works with and across
n formal and informal professional and social networks to build long-term
n partnerships and connections in the life science industry.

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- Problem solving –
n Identifies, researches, and demonstrates logical reasoning to communicate




n critical information.

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- Rational Persuasion –, Active listening, Presents key factors influencing factors, and
n strategic goals to assist stakeholders in identifying solutions.

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- Interpersonal Awareness – Ability to be aware of
n how actions, ideas, and communication can/does affect people and their
n outcomes.

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- Agility – Meets objectives by responding to competing
n and changing priorities and multiple tasks under inflexible timelines.

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Requirements n

REQUIRED EDUCATION AND WORK EXPERIENCE:

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- Bachelor’s Degree in Engineering
n or Life Science.

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- Minimum 2 years
n of experience in Quality Assurance, Validation, Manufacturing Quality, or
n Project Quality within the pharmaceutical, biotechnology, medical device, or
n other regulated industries.

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- Demonstrated
n experience reviewing and approving GMP documentation including risk
n assessments, validation protocols, qualification documents, change controls,
n deviations, and CAPAs.

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- Experience
n supporting technology transfer, process validation, qualification, engineering,
n manufacturing, or capital projects.

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- Working knowledge of cGMP, GxP, FDA, EMA, TGA, PIC/S, and
n international regulatory requirements.

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- Strong technical writing and document review skills.

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- Ability to
n build and maintain relationships with stakeholders across multiple functions
n and organizational levels.

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📌 Quality Assurance Specialist (Brisbane)
🏢 PSC Biotech
📍 Brisbane