QA Officer

Work Schedule

Environmental Conditions

Job Description

As part of the Thermo Fisher Scientific team youll 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 worlds 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 Youll Do:

Youll join our outstanding Qualityonthefloor 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 postproduction 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 SOPs and other documents to regulatory standards
• Support on qualityrelated issues
• Identify continual improvement opportunities
• Youll 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 workrelated 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 nonprofit 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 100000 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.

Apply today!

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.