Job Highlights
Not Disclosed
Posted 8 months ago
Job details
Key Responsibilities:
Internal
Qualifications & Experience
- 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).
Internal
- Operations
- Quality Assurance
- Quality Control Scientist
- Other Thermo Fisher Scientific Business both within and external to the PSG
- Equipment/Contract Laboratory/Maintenance vendors and contractors
Qualifications & Experience
- 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.
- At least 1 - 2 years’ experience in the the pharmaceutical and/or pharmaceutical industry aligned to Analytical and Quality Control fields.
- 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.
- 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.
- Managing Relations: Demonstrates the ability to manage customer demands with respective 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.
Benefits Offered?
- No
Bonus Offered?
- No
Travel Required?
- No
Location:
- Australia
Global Experience Needed?
- No
Specialized Experience Needed?
- No
Apply before:
- Apr 15, 2024
Company Overview
Thermo Fisher Scientific
Current Openings: 0
About Thermo Fisher Scientific Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. For more information, please visit www.thermofisher.com.
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