Work ScheduleStandard (Mon-Fri)Environmental ConditionsAdherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, OfficeJob DescriptionAs 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 SystemPerform real-time batch record reviews, including post-production protocolsConduct routine audits of logbooks for completeness and cGMP compliancePerform final QA review and approval of batch documentationActively participate in deviation investigationsApprove quality records (Deviations, Out Of Specifications, CAPAs, Audit findings)Review and approve QA controlled documentsSupport compliance to systems timeframes for related tasksIssue protocols to other departments as requiredPerform quality functions including rejects and vial thawUpdate SOPs and other documents to regulatory standardsSupport on quality-related issuesIdentify continual improvement opportunitiesWork collaboratively with Operations (USP, DSP, MBP), Warehouse, Validation, Engineering, Process Engineering, QC as well as external clients and Regulatory AgenciesKeys to Success:Education:Tertiary level in Biotechnology, Biochemistry, Microbiology, Chemistry, Pharmacology, or equivalentKnowledge, Skills, Abilities:Minimum 3 years of GMP experiencePreferably, minimum 1 year of industry work experience in a Quality Assurance role within a GMP regulated environmentKnowledge of pharmaceutical cGMP quality systems and international cGMP regulations and guidelinesStrong communication skillsStrong written, verbal and presentation skillsAdhere to EHS policies and procedures and ensure a safe workplaceEnsure hazardous conditions and incidents are reportedNot knowingly pollute the environmentBenefits: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 EqualityOur 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 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, where diverse experiences, backgrounds and perspectives are valued.Apply today! mo 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.#J-18808-Ljbffr