QA & Compliance Specialist — 18-Month Contract

Boehringer Ingelheim Pharmaceuticals, Inc.; Sydney; On-site; AUD 70,000 - 100,000; Full time

Job summary

Boehringer Ingelheim Pharmaceuticals, Inc. is seeking a Quality Assurance Associate on an 18-month contract in Australia and New Zealand.

The role supports the PQS within QS&C to ensure compliance with regulatory requirements and maintains the quality system, supplier qualification, and non-transactional QA activities. Responsibilities include deviation handling, CAPAs, KPI monitoring, and supporting local QA processes, training programs, and self-inspections.

Qualifications

• Bachelor’s degree in a relevant scientific discipline (e.g., Chemistry, Pharmacy, Life Sciences).
• 2–5 years’ experience in the Human Pharmaceutical, Veterinary Medicine, Medical Device, or Food Industries.
• Basic knowledge of regulatory requirements for the pharmaceutical industry.
• Intermediate level competency in core Microsoft Office applications (Word, Excel, Power Point, Outlook).
• Experience with QA IT platforms such as GoTrack (TrackWise).
• Experience with ERP systems, such as SAP.
• GMP training from a recognized provider would be an advantage.

Responsibilities

• Support the local Supplier Lifecycle Management program in accordance with local regulations and corporate requirements, including supplier selection, evaluation, qualification, QA agreements, CAPA verification, and monitoring.
• Maintenance of quality system processes and related documentation (SOPs, Quality Agreements, Supplier Management).
• Raise and review deviations, investigations, CAPAs, Quality Risk Management & Change Control records as per procedures.
• Monitor quality related processes, prepare reports for Quality Management Review, and trend data to reverse adverse trends.
• Develop and implement local quality processes and procedures ensuring regulatory compliance.
• Support development of the local QA training programme and delivery of training material.
• Participate in self-inspections as co-auditor and/or auditee as required.
• Maintain appropriate quality records as required by procedures.
• Provide support to product quality team for releases, complaints and returns.
• Undertake any other duties directed by the Head of Commercial Quality.

Skills

QA experience

Regulatory knowledge

Negotiation skills

Education

Bachelor's degree in a relevant scientific discipline

Tools

MS Office (Word, Excel, PowerPoint, Outlook)

GoTrack (TrackWise)

SAP

Job description

Boehringer Ingelheim Pharmaceuticals, Inc. is seeking a Quality Assurance Associate on an 18-month contract in Australia and New Zealand.

The role supports the PQS within QS&C to ensure compliance with regulatory requirements and maintains the quality system, supplier qualification, and non-transactional QA activities. Responsibilities include deviation handling, CAPAs, KPI monitoring, and supporting local QA processes, training programs, and self-inspections.