Job Title

Join to apply for the Engineer/Scientist I, QC role at Thermo Fisher Scientific.Environmental Conditions: Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting, No contact lens allowed; prescriptive glasses will be provided, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.).Work Schedule: Standard (Mon-Fri).About us: As part of Thermo Fisher Scientific, youll discover meaningful work that impacts globally. Join us in bringing our Mission to life to enable our customers to make the world healthier, cleaner, and safer. We develop solutions for challenges like environmental protection, food safety, and cancer cures.Role Location: Brisbane. This is a Fixed Term, 12-month Contract role.Position Summary: Our Brisbane site manufactures bio-pharmaceutical products aligned with regulatory standards (TGA, FDA, EMA). Responsibilities include supporting client studies, ensuring timely, accurate data, managing external testing, and maintaining quality systems.Key Responsibilities:Coordinate with Clients and Project Managers on quality requirements for stability studies, batch testing, and external testing.Collaborate with QC Labs, QA, Program Management, Logistics, external labs, vendors, and contractors.Generate shipping documentation and review test reports from external labs.Perform aseptic aliquoting of bulk samples.Support QC lab testing to meet regulatory guidelines.Manage Change Control, Deviations, CAPA, OOS, OOT, and document management systems.Apply risk assessment tools (FMEA, fishbone diagrams, HAZOP).Engage with QA and QC teams to meet batch release and delivery timelines.Support PPI activities and ensure documentation traceability and accuracy.Assist in generating and approving Work Flows and MLPs in gLIMS.Follow EH&S guidelines, Quality Standards, SOPs, and maintain licenses.Mentor and train QC staff.Perform other duties as directed.Keys to Success:Bachelor of Science in Bio-Technology, Chemistry, or related field.At least 2 years experience in pharmaceutical or biotech industry, focusing on Analytical and Quality Control.Knowledge of test method development, qualification, validation.Understanding of cGMP and QMS including deviations, CAPA, OOS, OOT, document management, change control.Ability to work in a fast-paced environment with diverse teams.Experience with stability studies in biopharma.Attention to detail and good communication skills.Proficiency in Microsoft Office, Smartsheets, LIMs Sample Manager.Adaptability, collaboration, continuous improvement mindset, customer focus, initiative, and quality orientation.Benefits: Join us and enjoy health & wellbeing programs, flexible work arrangements, extra leave options, charitable giving, learning and development opportunities.Our Mission is to enable our customers to make the world healthier, cleaner, and safer. We value diversity and inclusion. Apply now: #J-18808-Ljbffr