Position Overview:

The Senior Quality Associate – Validation is responsible for ensuring the integrity, accuracy, and regulatory compliance of raw materials, in-process samples, and finished products. This position supports laboratory operations, method verification, data review, and compliance activities in alignment with TGA regulations, PIC/S GMP guidelines, and company SOPs..

Key Responsibilities:

● Assist with establishing all laboratory functions in accordance with GMP and GLP principles.

● Management of samples and coordination of testing done by external laboratories.

● Perform chemical, physical, and microbiological testing of raw materials, in-process samples, and finished probiotic products according to validated methods and specifications.

● Review analytical results, batch records, and laboratory documentation for accuracy and GMP compliance.

● Coordinate and oversee method development, method verification/validation, and stability studies as required.

● Investigate out-of-specification (OOS), out-of-trend (OOT), and non-conformance results, and support root cause analysis and CAPA implementation.

● Support equipment qualification, calibration, and routine maintenance in accordance with GMP and GLP.

● Manage reference and retention samples.

● Maintain good documentation practices (GDP) and ensure timely data entry and reporting.

● Liaise with QA, Production, and R&D teams to support product release, investigations, and continuous improvement initiatives.

● Assist in training and mentoring of junior laboratory staff.

● Contribute to internal and external audits, including TGA inspections.

● Support the Head of Quality with Release for Supply

Key Relationships:

● Quality Assurance

● Quality Control

● Manufacturing and Packaging Operations

● Regulatory Affairs

● Product Development

● TGA Inspectors and third-party auditors

● External vendors and service providers

Qualifications & Experience:

Essential:

● Bachelor’s degree in Microbiology, Chemistry or Biotechnology, or related field.

● Minimum 5 years' experience in a GMP-regulated QC laboratory.

● Strong knowledge of PIC/S Guide to GMP, validation principles, TGA regulations, and Australian regulatory environment for complementary medicines.

● Demonstrated ability to write and review technical and regulatory documents.

● Strong understanding of risk management and quality systems.

Desirable:

● Experience in a complementary medicine or probiotic manufacturing facility.

● Project management experience or relevant certification.

Key Competencies:

● High attention to detail and documentation accuracy.

● Strong analytical and problem-solving skills.

● Effective written and verbal communication.

● Ability to manage multiple projects and priorities.

● Leadership and mentoring capabilities.

● Collaborative team player with a proactive mindset.

Performance Measures:

● Compliance with internal SOPs and regulatory requirements.

● Timely completion of validation projects.

● Audit readiness and minimal audit findings.

Work Environment:

This role is primarily site-based, operating within GMP laboratory environments. Occasional extended hours may be required.