Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description At Thermo Fisher Scientific, each one of our 75,000 outstanding minds has a unique story to tell. Surrounded by collaborative colleagues, you'll have the support and opportunities that only a global leader can give you. Our respected, growing organization has an outstanding strategy for the near term and beyond. Take your place on our strong team, and help us make important contributions to the world! Position Summary: This is a 12-month fixed term contract role for a Quality Control (QC) Scientist, customer facing role as QC representative for specific projects. You will be required to present QC scope to the client in kick-off meetings, independently liaise with clients regarding standard work scope. Confidently handle client queries, expectations, and challenges. Key Responsibilities: Support overall QC planning by supplying and updating relevant dates as agreed in the project team. Author QC specific batch documentation including Sampling Plans, specification documents, qualification and validation protocols and reports in line with Patheon policies and regulatory guidelines. Review protocols, data, and reports. Prepare data in support of specification discussions and facilitate specification council meetings. Investigate and evaluate new methods/techniques, judge their scientific soundness, and decide on the feasibility of implementation at the Patheon Brisbane site. Independently initiate and handle change control activities ensuring adherence to cGMP and EH&S guidelines. Liaise with QC laboratory teams to draft test methods. Support in developing relevant test methods for use. Assist QC laboratory team members with execution of analytical studies and troubleshooting method performance where relevant. Work directly with the program management teams to ensure analytical contractual stages and timelines for customer projects are met. Ensure customer satisfaction and expectations are maintained in the most profitable way. Monitor new technologies that are relevant to the QC department, which may offer a more cost effective and robust solution to the business. Ensure the scientific integrity of the QC teams is maintained, working closely with the data integrity officer. Facilitate atypical, out of specification or out of trend investigations with the team to ensure swift resolution, recommending appropriate resolution. Practical application of various risk assessments tools (i.e., failure mode effect analysis, fishbone diagrams, hazard, and operability studies) and ability to directly develop, participate, and advise others on the appropriate and efficient application of these processes. Practical application of the Quality System, Change Control, Deviations, CAPA, OOS and OOT, Document Management, related to the Quality Control Department. Assist with PPI projects. Perform any other legitimate duties as advised by the Senior Manager, QC (or delegate). Minimum Requirements/Qualifications: Minimum 3-5 years of GMP experience; Demonstrated client-facing experiences, able to confidently handle client's expectations; Have strong analytical skills and analytical document writing experience ; Good at communication in-person, via teleconferences, and through e-mails. Attend to details and able to work in fast-paced 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. Flexibility: Balance your work and personal life with flexible arrangements. 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. 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.
