QA Engineer I in Brisbane, Australia

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

About Us:

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

Location:

This role reports in to the Quality Systems Supervisor and is based on-site at our Brisbane location.

Position Summary:

The Brisbane site has facilities for developing and manufacturing biopharmaceutical products for clinical trials and commercial use. They follow regulatory requirements from TGA, FDA, EMEA, ICH, and other agencies. The QA Engineer will join our outstanding Quality Systems team and assist the Validation and Engineering team with quality support.

What You’ll Do:

• Drive compliance to the Quality Management System

• Timely review and approval of Process Validation / Equipment Validation documents (e.g., Microbial Mapping validation protocols, resin re-use protocols)

• Actively participate in deviation investigations

• QA Approval of quality records including Deviations, CAPAs, Audit findings

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

• Support compliance to systems timeframes for associated tasks (e.g., Change Control actions, DR investigations, processing CAPAs)

• Issue protocols as the need arises to other departments

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

• Serve as a resource to the operational areas on quality related issues

• Identification of continual improvement opportunities

• Participate in Risk Assessments

• Any other legitimate duties requested by QA Systems Supervisor

• Collaborate with Internal Validation, Engineering, Process Engineering teams and externally with clients and Regulatory Agencies

Keys to Success:

Education:

• Tertiary Academic level in a relevant field (Biotechnology, Biochemistry, Microbiology, Chemistry, Pharmacology)

Experience and Skills:

• Experience working within a GMP regulated environment

• Preferably, 2-3 yrs proven experience in Quality Assurance in a GMP environment

Skills & Attributes:

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

• Strong interpersonal skills – both written and verbal

• Experience working on risk management projects

• Follow EHS policies and procedures and ensure a safe workplace environment

• Ensure hazardous conditions, hazardous actions, incidents and near-miss incidents are reported

• Not knowingly pollute the environment

Benefits:

Join the team and take advantage of these benefits! Apply now to learn more about the full range of benefits we offer.

• Enjoy comprehensive benefits, wellness programs, and an Employee Assistance Program that prioritize your health and wellbeing.

• Flexibility: Balance your work and personal life with flexible arrangements.

• Extra Leave: Benefit from generous leave policies, including the option to purchase additional leave, paid birthday leave, and company paid parental leave.

• Charitable Giving & Volunteering: Make an impact with paid volunteer time to support non-profit organizations that matter to you.

• Learning & Development: Advance your career with access to online courses via Thermo Fisher Scientific University Plus and LinkedIn learning, workshops, and mentorship programs for continuous learning and skill development.

Thermo Fisher Scientific Australia WGEA Employer of Choice for Gender Equality

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch (https://jobs.thermofisher.com/global/en/5-reasons-to-work-at-thermo-fisher-scientific) as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values – Integrity, Intensity, Innovation and Involvement – working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific (https://corporate.thermofisher.com/us/en/index.html) , where diverse experiences, backgrounds and perspectives are valued.

Apply today! http://jobs.thermofisher.com

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.