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Quality Assurance Officer

Thermo Fisher Scientific

Job Description

Quality Assurance Officer

Quality Assurance Officer

Thermo Fisher Scientific in ANZ

Our growing team of 1200+ employees work together to deliver world-class science products and solutions to a wide range of key markets. With commercial, manufacturing and distribution sites scattered across Australia and New Zealand, including Melbourne, Brisbane, Sydney, Auckland, Adelaide, Newcastle, and Perth, our scope covers life sciences; specialty diagnostics; food, dairy & beverage; environmental & industrial; healthcare and; analytical instruments including commercial, customer service, technical service, supply chain, finance and operations.

Job Title: QA Officer

Reports to: QA Operations Manager

Position Location: PSG Brisbane, 37 Kent Street, Woolloongabba, Australia

Number of Direct Reports: 0

How you'll make an impact:

The Brisbane site is a multi-product biopharmaceutical site with development and manufacturing facilities for biopharmaceutical products for clinical trials (Phase I, II and III) as well as commercial products. Manufacturing of biopharmaceutical products is required to be in compliance with regulatory requirements as defined by TGA, FDA, EMEA, ICH and other applicable regulatory agencies. The Quality Assurance group is responsible for ensuring compliance to the applicable cGMP requirements. You will join our unique Quality-on-the-floor program and assist the operational areas with real time quality support.

What will you do?

Drive compliance to the Quality Management System, by:

Performing real time batch record reviews. This includes reviewing protocols during the manufacturing process as well as post production to ensure the quality of the product.

Performing routine audits of logbooks used in the operations/QC areas for completeness and cGMP compliance.

Performing final QA review and approval of batch related documentation

Active participant in deviation investigations

QA Approval of quality records including but not limited to; Deviations, Out Of Specifications, CAPAs, Audit findings etc.

Review and approval of QA controlled documents within the Quality Management System.

Supports compliance to systems timeframes for raising, processing or performing associated tasks (i.e. Change Control actions, DR investigations, processing CAPAs)

Issuing protocols as required to other departments

Perform quality functions including rejects, vial thaw, drug substance shipping as required

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

Serving as a resource to the operational areas on quality related issues.

Identification of continual improvement opportunities

Conducting Internal Audits

Participating in Risk Assessments

Any other legitimate duties requested by QA Manager.

How will you get here?

Minimum 3 years of experience in a Tertiary Academic level in a relevant discipline (Biotechnology, Biochemistry, Microbiology, Chemistry, Pharmacology, or equivalent).

Experience working in a GMP regulated environment

What will put you ahead of the competition?

Knowledge of pharmaceutical cGMP quality systems and international cGMP regulations and guidelines.

Strong communication skills

Strong written, verbal and presentation skills

What’s in it for you?

A competitive salary and performance related bonus structure

Access to Thermo Fisher’s global University

Exposure to market leading cutting-edge technologies

Development opportunities as part of a rapidly growing global organisation

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