Thermo Fisher Scientific

Senior Quality Control Technician (BB-4AD26)

Found in: Neuvoo AU

Reports to: Quality Control Supervisor, Biochemistry
Position Location: Woolloongabba, Brisbane
Permanent Full Time – 2 Opportunities

Our growing team of 1200+ employees work together to deliver world-class science products and solutions to a wide range of key markets. With commercial, manufacturing and distribution sites scattered across Australia and New Zealand, including Melbourne, Brisbane, Sydney, Auckland, Adelaide, Newcastle, and Perth, our scope covers life sciences; specialty diagnostics; food, dairy & beverage; environmental & industrial; healthcare and; analytical instruments including commercial, customer service, technical service, supply chain, finance and operations.

How you'll make an impact:
The Thermo Fisher Scientific 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.

What will you do?
  • 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.
  • Demonstrate orking experience of equipment used for execution of test records ie icIEF CE-SDS, UPLC, HPLC.
  • 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).

  • How will you get here?
  • Hold a Bachelor of Science (Bio-Technology, Chemistry, or closely related degree).
  • Post Graduate qualifications would be preferred.
  • At least 1-2 years’ experience in the pharmaceutical and/or pharmaceutical industry aligned to Analytical and Quality Control fields.

  • What will put you ahead of the competition?
  • Previously or currently working with icIEF CE-SDS, UPLC, HPLC equipment
  • 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.

  • What’s in it for you?
  • A competitive salary and performance related bonus structure
  • Access to Thermo Fisher’s global University
  • Exposure to market leading cutting edge technologies
  • Development opportunities as part of a rapidly growing global organisation
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