Project Specialist- Chemistry

Fantastic opportunity to join a highly regarded government radiopharmaceutical facility in a technical leadership role, based in Lucas Heights.
Benefits:

• Permanent, full-time role.
• Technical leadership position.
• 15.4% Super and additional leave days.
• Generous shift loading.
• Health & Wellbeing Programs.
• Free parking.
• Childcare on site.

Key Responsibilities:

• Act as a product specialist, managing continuous improvement projects related to the product(s) under their portfolio.
• Assist the QC Manager with strategy development, planning and implementation as a product specialist, and CI coordinator.
• Contribute to, manage, and lead complex continuous improvements projects that are not part of routine work.
• Ensure that all quality control activities performed are carried out in a manner that complies with the requirements and regulations.
• As a technical expert, train, coach and develop staff to ensure technical knowledge is shared across the wider Quality Team. Provide advice and guidance to staff.
• Utilise QMS functions relevant to the Quality Section
• Active engagement in safety initiatives, safety investigations, and coordinate implementation of relevant safety-related actions.
• Provide technical information, specifications, and validation information for submissions to regulating authorities and customers.

The successful candidate will have:

• Relevant degree qualifications or alternatively Advanced Diploma / Diploma in Chemistry supported by relevant experience.
• Demonstrated extensive experience in chemical analysis, in particular with HPLC and ICP-MS, within a GMP environment.
• Experience in TGA, FDA, ISO and NATA audits and regulations desirable.
• Knowledge of and experience using statistical techniques.
• Experience in validation of analytical method and instrumentation desirable.
• Knowledge of relevant nuclear and pharmaceutical production regulations and legislation.
• Pro-active, deadline driven, and reliable in following through with actions.
• Experience with QCMS will be highly regarded.
• Ability to work on a shift schedule, including one Sunday each month. No night shifts will be required.