Work Schedule Flex with On Call Duty 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, Warehouse Job Description Position Summary: Join Thermo Fisher Scientific Inc., a global leader in scientific innovation, as a Quality Assurance Associate in Brisbane. This role plays a crucial part in our dedication to producing biopharmaceutical products that align with international quality standards. Reporting to the Head of Quality Assurance, you will coordinate the implementation of vital quality systems, with a focus on Quality Risk Management, Global TrackWise administration, Document Management, oversight of Quality metrics, and trending of Deviations. Key Responsibilities: Furnish day-to-day aid within the Quality on the Floor Team, arranging, performing, and recording all duties. Efficiently fulfill responsibilities as part of the Quality Assurance department, positively impacting the site's quality management system. Propel and back QA on the Floor team goals and objectives to synchronize with Quality and business strategies. Ensure manufacturing activities adhere to cGMP and standard operating procedures. Offer real-time quality support, including cGMP mentorship, document review, approval, and deviation handling. Review batch records within standard timelines required for batch disposition. Support continuous improvement (PPI) initiatives to realize cost savings and drive efficiency. Build effective working relationships with key internal collaborators to foster a collaborative work environment. Participate in and engage with Quality Management Review. Assist in regulatory and client audits, from readiness activities to direct engagement with auditors, ensuring successful inspection outcomes. Apply various risk assessment tools practically and advise others on their efficient application. Apply the Quality System daily, including Change Control, Deviations, CAPA, OOS/OOT, and Documentation Management. Carry out any other legitimate responsibilities as instructed by the Head of Quality Assurance or Site Quality Head. Frequent Contacts: Internal: All internal departments External: Regulatory agencies and customers Minimum Requirements/Qualifications: Qualifications & Experience: Tertiary education in a science or engineering-based field (e.g., biopharmaceuticals manufacture, biotechnology, process technology) or relevant industry experience. Post Graduate qualifications are beneficial. At least 3 years of experience in the pharmaceutical industry aligned to Quality Assurance. Excellent knowledge of cGMP. Desire to work in a highly dynamic, frequently changing environment with diverse perspectives. Strong written, verbal, and interpersonal communication skills. Strong ability to collaborate effectively and build rapport with internal and external collaborators. Good knowledge of Microsoft applications. Knowledge of SmartSheets is desirable. Skills & Attributes: Continuous Improvement: Ability to challenge the status quo to improve outcomes. Adaptability: Ability to adapt to day-to-day business requirements. Collaborating: Skill in collaborating with diverse departments and colleagues. Customer Focus and Integrity: Dedication to delivering on promises made to customers. Commencing Activity: Proficiency in functioning solo and supervising prearranged assignments. Managing Relations: Ability to balance customer demands with business requirements and timelines. Quality Orientation: Ability to interpret and apply GMP principles, with strong attention to detail. 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 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 (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.
