QC Team Leader - Physiochemistry & Raw Material

Job description

Work Schedule Standard (Mon-Fri) Environmental Conditions Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Cold Room/Freezers -22degreesF/-6degrees C, Laboratory Setting, Loud Noises (Equipment/Machinery), 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.), Strong Odors (chemical, lubricants, biological products etc.), Warehouse, Will work with hazardous/toxic materials, Working at heights Job Description As 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 InformationThe TFS site in Brisbane manufactures many new biopharmaceutical products for several stages of clinical trials. The extent of the application of the c-GMP system and the degree of testing varies with the stage of the product. The Quality Control lab is responsible for all testing of materials and products, including the testing of final products that is a basis for release to the market. Proper outsourcing of certain tests is part of this responsibility. In case no suitable test method is available, test methods need to be developed, often based on technology transfer from the client. The work in the Quality Control lab is a mixture of development tests, project-related activities and routine testing for which an adequate organization need to be managed. About the Role: The Physiochemistry and Raw Materials team plays an integral role in the production and disposition of pharmaceuticals at our site. Our team is responsible for performing physio-chemistry analysis on various samples and coordinates the QC release of relevant We are a quickly expanding site with ever growing opportunities. We believe our workforce are our greatest asset and are passionate about nurturing and developing future talent. What You'll Do:Responsible for day-to-day management of the Physiochemistry and Raw Materials team, including planning of activities and resources, execution of analysis. Peer review and technical review of analyses for completeness and cGMP compliance. Ensures raw materials are QC released for use in operations, adhering to pharmacopoeial standards and strict timelines and deliverable dates. Participate in internal and external client and regulatory audits, acting as an SME and competently representing all functions of the team. Establishes the goals and objectives of the team, ensuring a high level of analytical quality. Leads/manages the performance of the team through effective key performance indicators (KPIs), targets and goal setting. Leading, coaching and motivating members of the team. Knowledge of equipment used for execution of test records (pH, conductivity, OSMO, etc.) Effective execution of test records for customer requirements. Identify, report and investigate non-conformances and OOS/UR results and inform Supervisor and Manager. Understanding of the Quality Control practices and principles across the full spectrum of site manufacturing services. Support in the practical application of various risk assessment 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. Take a lead role within the team in the practical application of the Quality System, Change Control, Deviations, CAPA, OOS and OOT, Document Management, related to the Quality Control Department. Perform any other legitimate duties as directed by the Manager, QC Operations (or delegate). EducationBachelor of Science (Biotechnology, Chemistry, or closely related degree). Post Graduate qualifications – beneficial. ExperienceAt least 1 year of experience in a leadership role. At least 5 years’ experience in the biopharmaceutical and/or pharmaceutical industry aligned to Analytical and Quality Control fields. Strong background in analytical theory and technical competency with laboratory analysis. Experience interpreting and applying cGMP principles, strong attention to detail, and accurate completion of test records. Strives for right first time in every task undertaken. Specific knowledge of Bio-pharmaceutical processes, Pharmaceutical guidelines and principals of, preferred. Familiarity with principles of Aseptic techniques Knowledgeable in cGMP practices Proven record of ability to work as a team member and independently as required. Good knowledge of Microsoft applications (e.g. Excel, Word, Outlook, PowerPoint). Good knowledge of Smartsheets – desirable. Knowledge, Skills, AbilitiesAbility to effectively communicate in multiple modalities (e.g. electronic, written, verbal, etc.) Ability to work on multiple projects simultaneously and demonstrate initiative to complete tasks according to company milestones / goal tree. Strong team working and collaborative skills. Adaptability: Ability to adapt to day-to-day business requirements. Collaborating: Demonstrates the ability to work with all departments and colleagues of varied backgrounds. Continuous Improvement: Demonstrates the ability to challenge the status quo to drive PPI. Customer Focus: Demonstrates the ability to deliver on promises made to customers i.e. meet agreed due dates. Initiating Action: Demonstrates the ability to work independently, and manage planned work. Ability to work on multiple projects or tasks simultaneously. Quality Orientation: Ability to interpret and apply cGMP principles, strong attention to detail and accurate completion of test records. Strives for right first time in every task undertaken. BenefitsJoin 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 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, where diverse experiences, backgrounds and perspectives are valued. Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discr