Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

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

Position Summary:

The role of Scientist - Quality Control is based on site at our Brisbane location and is a Fixed Term, 12-month Contract role. Our Brisbane site is focused on the manufacturing of biopharmaceutical products is required to be aligned with quality requirements as defined by the TGA, FDA, EMA and other regulatory agencies as applicable. To achieve compliance, quality systems are defined, implemented and maintained. The Quality Control team in Brisbane supports our client's studies that are required for the regulatory acceptance of their drug substance and drug product. Responsibilities include assuring timely, accurate and scientifically sound output of data from the Stability Studies, CoA/SoT generation for batch release, shipment of test samples, co-ordinating and accepting results from external third party test facilities, as required for each customer project.

• Independently liaise with Clients and Project Managers regarding their Quality requirements for stability studies, batch testing, external shipments and external contract testing. Efficiently handle Client queries, expectations and challenges. Supply and update relevant information and results to Project Managers and clients.
• Prepare Stability Study documentation including Stability Protocols, Statements of Testing and Stability Summary Reports.
• Generate shipping documentation and sample submission forms required for testing of Client samples at external facilities. Review and approve test reports supplied from external facilities
• Co-ordinate the approval of Batch Release Certificate of Analysis and In-process documentation Statement of Testing for Client product to facilitate on time disposition
• Demonstrate an understanding of Quality systems, practices and principles.
• Knowledge of Change Control, Deviations, CAPA, OOS and OOT, Document Management, related to the Quality Systems operating on the Brisbane site.
• Practical application of various risk assessments tools (i.e. failure mode effect analysis, fishbone diagrams, hazard and operability studies)
• Independently initiate activities ensuring alignment to EH&S.
• Ensures the scientific integrity of the Quality data reported is maintained by working closely with the data integrity officer
• Work with the Project Managers to ensure stability studies and external shipments/testing contractual stages and timelines for customer projects are met
• Engage with the Quality teams (QA and QC) to ensure batch release documentation and site delivery times are met in a profitable manner
• Work directly with the program management team to ensure customer requirements and expectations are maintained and identify and report any non-conformances to site Quality SOPs directly to Supervisor and QC Manager or delegate
• Author and review Quality protocols and reports in line with Patheon Brisbane internal policies, contracts and regulatory guidelines
• Support Quality Control laboratory teams as required to ensure relevant testing is performed on time and ensure accordance with Regulatory Guidelines, in performance and guidelines for Client stability studies
• Prepare data to support specification discussions and present in specification council meetings
• Support PPI activities for the business
• Ensure traceability and legibility of all QC documentation and ensure effective execution of documentation records for client requirements
• Support generation and approval of Work Flows and MLPs in gLIMS
• Enter and authorise results in gLIMS
• Work within EH&S guidelines, Corporate Quality Standards, Standard Operating Procedures and data integrity, maintain the Companies TGA and other manufacturing licenses
• Collaborate with QC Labs, QA, Program Management, Warehouse and Logistics, process.3rd party contract labs, equipment/ /Maintenance vendors and contractors

• Bachelor of Science (Bio-Technology, Chemistry, or closely related degree).
• At least 2 years' industry work experience in the pharmaceutical industry aligned to Analytical and Quality Control fields
• Knowledgeable with test method development, qualification, validation.
• Knowledgeable in cGMP practices
• Enjoy working in a highly fast paced and frequently changing environment with a wide variety of people and perspectives
• Experience in stability studies suitable for the bio-pharmaceutical industry
• Good attention to detail as a team member and when working independently.
• Can communicate in multiple modalities (e.g. electronic, written, verbal, etc.)
• Ability to prioritise multiple Client programs and reports simultaneously.
• Understanding of Microsoft applications (e.g. Excel, Word, Outlook).
• Ability to use Smartsheets
• Knowledge of LIMs Sample Manager

• Adaptability: Ability to adapt to every day business requirements.
• Collaborating: Work constructively with all departments and colleagues of multicultural backgrounds.
• Continuous Improvement: Challenge current systems to drive process improvements.
• Customer Requirements: Always deliver on promises made to customers.
• Initiating Action: Work independently, and also show initiative in planned work. Ability to work on multiple projects or tasks simultaneously.
• Handling Relations: Demonstrates the ability to support customer demands within business requirements and agreed timelines.
• 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.

• Health & Wellbeing: Join a company that prioritizes your health & wellbeing with comprehensive benefits including company paid private health insurance and risk benefits insurance (via selected company provider), 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.