Quality Assurance Officer

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, 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.

About the Role:

The Quality Assurance group is responsible for ensuring compliance to the applicable cGMP requirements. This candidate will join our unique Quality-on-the-floor program and assist the operational areas with real time quality support.

What You'll Do:

• Performing real time batch record reviews. This includes reviewing protocols during the manufacturing process as well as postproduction 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 review and approval of Process Validation documents for example Microbial Mapping validation protocols, resin re-use protocols, cleaning validation protocols etc.

• 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.

Education

• Tertiary Academic level in a relevant discipline (Biotechnology, Biochemistry, Microbiology, Chemistry, Pharmacology, or equivalent).

Experience

• Minimum 3 years of experience in a GMP regulated environment.

• Preferably, minimum 1 year of experience in Quality Assurance in a GMP regulated environment.

Knowledge, Skills, Abilities

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

• Strong communication skills.

• Strong written, verbal and presentation skills.

Physical Requirements / Work Environment

• Adhere to EHS policies and procedures and ensure a safe and healthy workplace environment.

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

Other Important Information

• Able to work from the Banyo site approximately once every two weeks (around 10–15% onsite presence), ideally.

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.

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.