Quality Assurance Engineer (Biotech)

TL;DR

Quality Assurance Engineer (Biotech): Providing QA oversight for commissioning, qualification, validation, and technology transfer projects with an accent on GMP compliance and quality system management. Focus on ensuring regulatory adherence across engineering and manufacturing lifecycles while collaborating with cross-functional teams.

Location: Onsite in Melbourne, Australia

Company

hirify.global is a professional services firm providing quality and compliance solutions to the life science industry.

What you will do

• Provide QA oversight for engineering, validation, manufacturing, and capital projects.
• Review and approve GMP-related documentation including protocols, risk assessments, and quality records.
• Facilitate quality systems management including deviations, investigations, change controls, and CAPA.
• Ensure compliance with cGMP, GxP, and global regulatory requirements.
• Collaborate with Engineering, Manufacturing, and Regulatory teams to achieve project objectives.
• Support vendor qualification and supplier quality activities.

Requirements

• Bachelor’s Degree in Engineering or Life Science required.
• Minimum 4 years of experience in QA, Validation, or Manufacturing Quality within regulated industries.
• Demonstrated experience reviewing and approving GMP documentation.
• Experience supporting technology transfer, process validation, or capital projects.
• Working knowledge of cGMP, GxP, FDA, EMA, TGA, and PIC/S requirements.
• Strong technical writing and document review skills.

Culture & Benefits

• 12-month contract role.
• Opportunity to work on diverse capital projects in the life science sector.
• Focus on professional growth and industry partnership building.
• Collaborative environment working across multiple organizational levels.