Sr QC Technician

at  Thermo Fisher Scientific

MINIMUM REQUIREMENTS/QUALIFICATIONS:

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.

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.
• 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.

• 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).