Sr QC Technician

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 – QC Physiochemistry & Raw Material

Reports to: QC Physio-Chemistry Team Leader

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:

Manufacturing of biopharmaceutical products is required to be aligned with quality requirements as defined by the TGA, FDA, EMA and other regulatory agencies as applicable. To achieve compliance, quality systems are defined, implemented and maintained. The Quality Control Laboratory is responsible for the execution of Qualification/Validation Protocols, Technical Transfer (as applicable) and Performance of Quality Control tests.

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 Physiohemistry 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.
• 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 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). Background in analytical theory and technical competency with laboratory analysis. Knowledgeable with cGMP and various laboratory analyses, efficient sample workflows, in process controls, analytical testing and equipment maintenance/introduction.
• Ability to effectively communicate in multiple modalities (e.g. electronic, written, verbal, etc.), Good knowledge of Microsoft applications (e.g. Excel, Word, Outlook, PowerPoint).
• Ability to work on multiple projects simultaneously.
• Strong team-working and collaborative skills. Previous experience in leadership and personnel management-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.

Other Job Requirements:

Deliver the best technical and scientific solutions to improve product value. Build a culture of engagement, accountability and a shared commitment to excellence. Abide by all EH&S policies and procedures, operate our business in a safe, focused, responsible, and ethical fashion. Work safely and only perform tasks if currently competent and/or authorised, participate in EH&S activities such as; GEMBA walks, inspections, and risk assessments.

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.