Associate QA Officer

Work Schedule

Environmental Conditions

Job Description

At Thermo Fisher Scientific each one of our 75000 outstanding minds has a unique story to tell. Join us and contribute to our singular missionenabling our customers to make the world healthier cleaner and safer!

When youre part of the team at Thermo Fisher Scientific youll do important work. Surrounded by collaborative colleagues youll have the support and opportunities that only a global leader can give you. Our respected growing organization has an outstanding strategy for the near term and beyond. Take your place on our strong team and help us make significant contributions to the world.

Position Summary:

Manufacturing of biopharmaceutical products is required to be in compliance with international quality requirements as defined by TGA FDA EMA ICH etc. This role reports to the Materials Management Team Leader and is based in Brisbane. The roles main focus is to support the Materials Management Team in maintaining the material quality and compliance systems across the Brisbane site.

Key Responsibilities:

• Drafting article code forms
• Complete change notification impact assessments; draft and approve change notification change controls
• Assist in activities within the quality agreement system
• Assist in regulatory and client audits from readiness activities through to engagement
• Building and maintaining effective working relationships with key internal collaborators from other teams and departments that foster a collaborative work environment
• Participate in implementing continuous improvement (PPI) initiatives that realise cost savings and drive efficiency
• Updating SOPs and other documents to meet current regulatory and corporate standards
• Ownership of quality records including but not limited to deviations CAPAs Audit findings etc as required
• Participate in global projects and initiatives related to the remit of the Materials Management Team as required
• Perform any other legitimate duties as required by the Materials Management Team Leader

Frequent Contacts:

Internal

• QC USP DSP MBP WHS and Supply Chain

External

• Suppliers Contractors

Minimum Requirements/Qualifications:

Qualifications & Experience

• Tertiary education in science or engineering-based field (i.e. biopharmaceutical manufacture biotechnology process technology) or relevant validated experience
• Previous experience in the pharmaceutical industry

Skills & Attributes

• Good knowledge of cGMP
• Desire to work in a highly dynamic frequently changing environment with a wide variety of people and perspectives
• Flexible and adaptable attitude
• Strong written verbal and interpersonal communication skills
• Strong collaborative skills with the ability to build rapport with internal and external customers

Other Job Requirements:

• Adhere to OHS policies and procedures and ensure a safe and healthy workplace environment
• Adhere to the Chain of Responsibility obligations under the Australian Heavy Vehicle National Law

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race color religion sex sexual orientation gender identity national origin protected veteran status disability or any other legally protected status.