Senior Quality Associate – New Products Introduction (NPI)

The Senior Quality Associate – New Products Introduction (NPI) is responsible for ensuring the successful introduction of new products from ideation to production while maintaining integrity, accuracy, and regulatory compliance of raw materials and finished products. This position supports R&D operations, manufacturing trials, method verification, and compliance activities in alignment with TGA regulations, PIC/S GMP guidelines, and company SOPs.

Key Responsibilities:

Support R&D operations by providing quality inputs on new formulas, raw materials, packaging materials and dosage forms.

Support in Supplier selection and approval process.

Plan, coordinate and oversee the quality aspects of new products development or manufacturing trials and feedback to head of quality and project team.

Review new products 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.

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 quality staff.

Contribute to internal and external audits, including TGA inspections.

Support 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.

Familiarity with complementary medicine regulations under the Therapeutic Goods Act 1989

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 R&D projects and new products introductions.

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.