Senior QC Technician - QC Biochemistry

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

At Thermo Fisher Scientific, each one of our 75,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.

When you’re part of the team at Thermo Fisher Scientific, you’ll do important work. 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 exceptional strategy for the near term and beyond. Take your place on our strong team, and help us make significant contributions to the world.

Job Title: Sr. QC Technician - Biochemistry

Reports to: QC Team Leader, Biochemistry  

Group / Division: PSG / DSD

Career Band: 03

Job Family: Operations

Job Sub Family: Quality Control

Job Code: OPS.QCOP.P03

Job Track: Associate

Position Location: PSG Brisbane Australia

Number of Direct Reports: 0

Position Summary: The TFS site in Brisbane manufactures many new biopharmaceutical products for several stages of clinical trials. The extent of the application of the cGMP 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.

Key Responsibilities:

• Participate in activities related to analytical development and QC test strategy to meet or support the client’s requirements and/or expectations.
• Ensure that the execution of studies is according to current guidelines.
• Contribute to the maintaining of TGA and other licenses.
• Sound knowledge of equipment used for execution of test records (SoloVPE, qPCR, Binding ELISA, Endotoxin, etc.).
• Assessment of analysis against predefined specification.
• Effective execution of test records for customer requirements.
• Peer review of analysis for completeness and correctness.
• Assist QC Supervisor in review / approval of test records, where relevant.
• Identify and report non-conformances and OOS/UR results directly to Supervisor and Sr. Manager, QC or delegate.
• Contribute to the effective delivery of high value analytical services to clients.
• Understanding of the Quality Control practices and principles across the full spectrum of site manufacturing services.
• Support in the 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.
• Support in the practical application of the Quality System, Change Control, Deviations, CAPA, OOS and OOT, Document Management, related to the Quality Control Department.
• Assist with site PPI projects.
• Perform any other legitimate duties as directed by the Senior Manager, QC (or delegate).

Frequent Contacts:

Internal

• Operations
• Quality Assurance
• Quality Control Scientist

External

• Other Thermo Fisher Scientific Business both within and external to the PSG
• Equipment/Contract Laboratory/Maintenance vendors and contractors

Minimum Requirements/Qualifications:

• Bachelor of Science (Bio-Technology, Chemistry, or closely related degree).
• Post Graduate qualifications – beneficial.
• Specific knowledge of Bio-pharmaceutical processes, Pharmaceutical guidelines and principals of, preferred.
• Familiarity with principles of Aseptic techniques, preferred.
• Knowledgeable in cGMP practices
• Background in analytical theory and technical competency with laboratory analysis, desirable.
• Ability to work in a highly dynamic, frequently changing environment with a wide variety of people and perspectives.
• Proven record of ability to work as a team member and independently as required.
• Ability 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.
• Good knowledge of Microsoft applications (e.g. Excel, Word, Outlook, PowerPoint).
• Good knowledge of Smartsheets – desirable.

Skills & Attributes

• Adaptability:  Ability to adapt to day-to-day business requirements.
• Collaborating:  Demonstrates ability to work with all departments and colleagues of varied backgrounds.
• Continuous Improvement:  Demonstrates the ability to challenge the status quo to improve outcomes.
• 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.
• Managing Relations:  Demonstrates the ability to manage customer demands with respective business requirements and agreed timelines.
• Quality Orientation:  Ability to interpret and apply GMP principles, strong attention to detail and accurate completion of test records.

Other Important Information:

The Thermo Fisher Scientific Brisbane site is a multi-product biopharmaceutical site with development and manufacturing facilities for pharmaceutical products for clinical trials (Phase I, II and III). The extent of the application of the cGMP system and degree of testing varies with stage of production. The Quality Control Laboratory department is responsible for testing the material and products, including the tests that are required by the customer for intermediates and final material as well as all the routine testing for raw materials, facilities, utilities, and manufacturing systems. Proper outsourcing of certain tests is part of the responsibility. In case no suitable test method is available, test methods need to be developed, often based on technology transfer from the customer. The work in the Quality Control Department is a mixture of development tests, project related activities and routine testing of which an adequate organization is to be managed

Other Job Requirements:

• Provide industry-leading customer experience.
• Be the highest quality, most efficient and flexible provider.
• Deliver the best technical and scientific solutions to enhance product value.
• Create a culture of engagement, accountability and a shared commitment to excellence.
• Operate our business in a compliant, safe disciplined, responsible, and ethical fashion.
• Abide by all EH&S policies and procedures.
• Work safely and only perform tasks if currently competent and/or authorised.
• Report hazardous conditions, hazardous actions, and incidents and near- miss incidents.
• Participate in EH&S activities such as; GEMBA walks, inspections, and risk assessments.
• Not knowingly pollute the environment.

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.