QA Officer in Brisbane, Australia

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.

Location/Division Specific Information:

This role reports in to the Team Leader Quality and sits within the Pharmaceutical Services Group (PSG)/ Drug Substance Division (DSD or equivalent experience), The role is Brisbane based, and is a permanent onsite role.

About the Role:

Brisbane site has facilities for developing and manufacturing biopharmaceutical products for trials and commercial use.

What You’ll Do:

You’ll join our outstanding Quality-on-the-floor program and assist the operational areas with real time quality support. This is an ever growing team of highly skilled Quality professionals, and you will have every opportunity to excel and further your career within the Quality Team.

Key Responsibilities:

• Drive compliance to the Quality Management System

• Perform real time batch record reviews, including post-production protocols

• Conduct routine audits of logbooks for completeness and cGMP compliance

• Perform final QA review and approval of batch documentation

• Actively participate in deviation investigations

• Approve quality records (Deviations, Out Of Specifications, CAPAs, Audit findings)

• Review and approve QA controlled documents

• Support compliance to systems timeframes for related tasks

• Issue protocols to other departments as required

• Perform quality functions including rejects and vial thaw

• Update SOP’s and other documents to regulatory standards

• Support on quality-related issues

• Identify continual improvement opportunities

• You’ll work collaborative with Operations (USP, DSP, MBP), Warehouse, Validation, Engineering, Process Engineering, QC as well as external clients and Regulatory Agencies

Keys to Success:

Education

• Tertiary level in Biotechnology, Biochemistry, Microbiology, Chemistry, Pharmacology, or equivalent

Knowledge, Skills, Abilities

• Minimum 3 years of GMP experience

• Preferably, minimum 1 year of indsutry work experience in a Quality Assurance role within a GMP regulated environment

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

• Strong communication skills

• Strong written, verbal and presentation skills

• Adhere to EHS policies and procedures and ensure a safe workplace

• Ensure hazardous conditions and incidents are reported

• Not knowingly pollute the environment

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 (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.