Senior QA Associate

About the Company

Join a global business headquartered in Melbourne delivering innovative products that make a difference in patient's lives.

Position overview

The Senior QA Associate assists with driving a continuous improvement culture to maintain the effectiveness of the Quality Management System, including control and administration of documentation, deviation process management, leading internal audit processes and preparing for and participating in audits by regulatory authorities/notified bodies.

Responsibilities

• Ensure documentation complies with the company's QMS requirements and relevant regulatory requirements and are completed timely.
• Assist QA Manager in performing QA product/raw material release activities by reviewing Batch Process Records, QC release testing, raw material/product specifications and labelling requirements in accordance with defined manufacturing timelines.
• Monitor manufacturing data for compliance and improvement opportunities.
• Undertake agreed internal audits in the capacity of lead or second auditor.
• Ensure that internal audits are conducted and engage in the process according to schedule, assign audit actions and review their implementation and effectiveness within allocated timeframes.
• Support the management of the Change Control process to ensure changes are appropriately risk assessed
• Participate at senior level in external audits by regulatory authorities/notified bodies.
• Review compliance activity and develop reports for QA Manager & senior management consideration.
• Analyse quality assurance gaps, and in coordination with QA Team, make necessary changes in consultation with process stakeholders in addressing the gaps.
• Assist department managers with staff training needs related to the quality management system and maintain the company training matrix.
• Act as 2IC to QA Manager, and when required, work at a higher level in their absence.

Requirements

• Degree qualification (minimum) in a science, biomedical/biotechnology, engineering or related discipline
• 3 years' plus experience in a quality related role with auditing and process improvement responsibilities within a medical device regulated by ISO13485 and/or GMP/FDA 21 CFR820.
• Demonstrated knowledge of quality systems and auditing processes.
• Demonstrated ability to maintain a high level of reporting, documentation and organisation.

If you are having difficulty in applying or if you have any questions, please contact Oliver Archer at +61 2 9054 7418.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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