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, 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.), Will work with hazardous/toxic materials, Working at heights
Job Description
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 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.
The QC Physiochemistry & Raw Material 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.
Key Responsibilities:
Sampling of raw material according to the guidelines and in a controlled environment.
Sound knowledge of equipment used for execution of test records (pH, conductivity, OSMO, 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 Physiochemistry Team Leader in review/approval of test records, where relevant
Identify and report non-conformances and OOS/UR results directly to Team Leader, 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 leading 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.
Assist with site PPI projects.
Perform any other legitimate duties as directed by the Team Leader or/and Manager, QC Operations (or delegate).
Frequent Contacts:
Internal: QC Scientist and Operations staff
External: Various equipment vendors / maintenance contractors
Minimum Requirements/Qualifications:
Qualifications & Experience
Bachelor of Science (Biotechnology, Chemistry, or closely related degree).
Post Graduate qualifications – beneficial.
At least 2 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.
Specific knowledge of Bio-pharmaceutical processes, Pharmaceutical guidelines and principals of, preferred.
Familiarity with principles of Aseptic techniques
Knowledgeable in cGMP practices
Background in analytical theory and technical competency with laboratory analysis
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 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.
