Quality Assurance Assistant

POSITION SUMMARY

The QA Assistant supports the Quality Assurance Team in ensuring that clinical laboratory studies are conducted in accordance with applicable regulations, including GCLP and organisational quality standards. This role is responsible for assisting with document control, audits, training tracking and QA documentation to maintain regulatory compliance in support of clinical development programs.

KEY RESPONSIBILITIES

• Assist with the preparation, organisation, review, and archiving of quality documentation, including study protocols, lab notebooks, raw data, and final reports.
• Support QA audits of internal and external GCLP-compliant laboratory activities, including data audits, facility inspections, and process audits related to clinical support studies.
• Maintain logs for internal QA audits, deviations, CAPAs, and study master schedules.
• Help track training records, SOP compliance, and qualification of personnel participating in regulated studies.
• Participate in document control activities, including the issuance and revision tracking of SOPs and study documents.
• Assist in reviewing final reports and critical data tables for GCLP compliance prior to study submission.
• Support audit preparation and responses for inspections by regulatory agencies (e.g., FDA, TGA).
• Communicate effectively with cross-functional teams including Clinical Operations, Regulatory Affairs, and Laboratory teams to ensure alignment on quality standards.
• Perform other duties as assigned by the Director of Quality to support QA oversight of clinical and preclinical studies.

SKILLS AND EXPERIENCE REQUIRED

• Bachelor of Science or equivalent with experience and/or training in quality assurance
• Experience working in a GxP environment highly regarded
• Familiarity with electronic systems used in clinical or laboratory environments (e.g. LIMS)
• Understanding of IND-enabling studies and their documentation requirements
• Ability to work independently and proactively anticipate needs of the company
• Responsive and able to work in a high-pressure environment with tight deadlines whilst ensuring tasks are completed to a high standard
• Strong attention to detail and exceptional record keeping
• Experience with biologics/microbiology preferred but not essential
• Experience working in a small company environment preferred but not essential

To apply, please send a CV and Cover Letter to [email protected].