Job Description

At Thermo Fisher Scientific, each one of our 75,000 outstanding minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.

Job Title: QA Officer

Reports to: Materials Management Team Leader

Group / Division: PSG / DSD

Career Band: 3

Job Family: Quality

Job Sub Family: Quality Assurance

Job Code: OPS.QAOP.P03

Job Track: Professional

Position Location: PSG Brisbane Australia

Number of Direct Reports: 0

Position Summary:

This position will support the Materials Management Team in maintaining the material quality and compliance systems across the Brisbane site. You'll get the opportunity to work on continuous improvement projects and collaborate with global teams. If this sounds like you, we'd love to hear from you!

We're passionate about ensuring our team is well-rounded; each member is trained to support every system within our remit. You'll receive ongoing training to build a strong understanding of our quality systems and how they impact our site and the wider PSG community.

Our team believes that quality culture and continuous improvement go hand-in-hand. We challenge each other every day to find better ways to integrate quality and efficiency in everything we do. If the idea of brainstorming system improvements excites you, you'll fit right in with our team!

Key Responsibilities:

Daily execution of the reject system, including processing reject forms and visiting the Banyo facility.

Drafting of article code forms.

Execute change notification impact assessments; draft and implement change notification change controls.

Assist in qualifying suppliers, manufacturers, and service providers.

Raise and process supplier complaints.

Assist in regulatory and client audits from readiness activities through to engagement as an SME if required.

Maintain effective working relationships with key internal stakeholders from other teams and departments that foster a collaborative work environment.

Participate in continuous improvement (PPI) initiatives that realise cost savings and drive efficiency.

Updating SOP’s and other documents to meet current regulatory and corporate standards.

Ownership of quality records including but not limited to; Deviations, Out Of Specifications, CAPAs, Audit findings etc as required.

Participate in global projects and initiatives related to the remit of the Materials Management Team, as required.

KPI reporting as required.

Perform any other legitimate duties as advised by the Materials Management Team Leader

Frequent Contacts:

Internal

All internal departments

External

Vendors, contractors, Regulatory Agencies, Customers and other Thermo Fisher Scientific Businesses both within and external to the PSG.

Minimum Qualifications & Experience

Tertiary education in science or engineering based field (i.e. biopharmaceuticals manufacture, biotechnology, process technology)

Previous experience in the pharmaceutical industry.

Good knowledge of cGMP.

Flexible and adaptable attitude.

Strong written, verbal, and interpersonal communication skills.

Strong collaborative skills with the ability to build rapport with internal and external stakeholders.

Skills & Attributes

Continuous Improvement

(Demonstrates the ability to challenge the status quo to improve outcomes)

Adaptability

(Ability to adapt to day to day business requirements)

Collaborating

(Demonstrates ability to work with all departments and colleagues of varied backgrounds)

Customer Focus and Integrity

(Demonstrates the commitment and ability to deliver on promises made to internal or external customers. i.e. meet agreed due dates)

Initiating Action

(Demonstrates the ability to work independently, and manage planned work)

(Ability to work on multiple projects or tasks simultaneously)

Managing Relations

(Demonstrates the ability to manage customer demands with respective business requirements and agreed timelines)

Quality Orientation

(Ability to interpret and apply GMP principles, strong attention to detail and accurate completion of test records)

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.

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.