Associate QA Officer

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office

Job Description

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.

What You'll Do:

• Drafting article code forms (site specification documents for materials)

• Executing 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 stakeholders 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 SOP’s 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

Education

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

• Experience in a cGMP environment is highly desired but not essential.

Experience

• Experience in a cGMP environment is highly desired but not essential.

Knowledge, Skills, Abilities

• 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 stakeholders

Benefits

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

• Health & Wellbeing: Join a company that prioritizes your health & wellbeing with comprehensive benefits, wellness programs, and an Employee Assistance Program providing confidential support for personal and work-related issues.

• 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 as our colleagues explain 5 reasons to work with us. As one team of 125,000+ 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, where diverse experiences, backgrounds and perspectives are valued.