QC Scientist - Biochemistry

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

Are you prepared to join a top-tier team in Brisbane, QLD, Australia, contributing to a healthier, cleaner, and safer world? Thermo Fisher Scientific empowers our clients to attain remarkable outcomes. Our team's outstanding performance and dedication to innovation guarantee our status as a premier player in the biopharmaceutical sector!

Position Summary

We are looking for an ambitious QC Scientist to join our growing team. Your role will be pivotal in ensuring the compliance of our biopharmaceutical products with international quality standards. You will be involved in the execution of qualification/validation protocols, batch release, and stability testing, contributing to our mission to deliver flawless products.

Key Responsibilities

• Participate in activities related to analytical development and QC test strategy to meet or support client requirements.
• Ensure studies are accomplished according to current guidelines and contribute to maintaining TGA and other licenses.
• Lead technical discussions and troubleshooting with sound knowledge of laboratory equipment (ELISA, Endotoxin, UV-VIS, SoloVPE, and qPCR).
• Transfer new analytical techniques and assays into the Biochemistry Laboratory.
• Identify and report non-conformances and Lab Incidents/OOS/UR results.
• 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.
• Update SOPs, work instructions, and test records.
• Lead the implementation of new equipment and processes.
• Conduct peer reviews of analysis for completeness and correctness.
• Ensure lab efficiency aligns with EH&S guidelines and Quality Standards.
• Lead, mentor, and motivate team members by delivering training.
• Assist with regulatory and client audits, representing aspects from the QC Biochemistry laboratory.
• Ensures the scientific integrity is maintained, working closely with the data integrity officer.
• Assist with periodic review of QC documentation.
• Perform any other legitimate duties as advised by the QC Team Leader (or delegate).

Minimum Requirements / Qualifications

• Bachelor of Science or equivalent experience in Biotechnology, Biochemistry, or a related field.
• Post Graduate qualifications are beneficial.
• 3-5 years of experience in the pharmaceutical industry aligned to Analytical and Quality Control.
• Knowledge of Bio-pharmaceutical processes, GMP principles, and laboratory analysis.
• Background in analytical theory and technical competency with laboratory analysis, desirable.
• Demonstrated capability to operate autonomously and collaboratively within a team.
• Ability to effectively communicate in multiple modalities (e.g. electronic, written, verbal, etc.)
• Proficient in Smartsheets, Microsoft Word, Excel, and PowerPoint.

Skills & Attributes

• Adaptability:  Ability to adapt to day-to-day business requirements.
• Collaborating:  Demonstrates ability to work with all departments and colleagues of varied backgrounds.
• Continuous Improvement:  Demonstrates the ability to challenge the status quo to improve outcomes.
• 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 GMP principles, strong attention to detail and accurate completion of test records.

Other Important Information

Our Brisbane site is a multi-product biopharmaceutical facility with development and manufacturing capabilities for clinical and commercial use. Our QC department ensures compliance with global quality standards, providing the best scientific solutions to improve product value.

Other Job Requirements

• Abide by all EH&S policies and procedures.
• Work safely and only perform tasks if currently competent and / or authorized.
• Report hazardous conditions, hazardous actions, incidents and near-miss incidents.
• Participate in EH&S activities (such as inspections and risk assessments) as directed.
• Be the highest quality, most efficient and flexible provider.
• Deliver the best technical and scientific solutions to enhance product value.
• Create a culture of engagement, accountability and a shared commitment to excellence.
• Operate our business in a compliant, safe disciplined, responsible, and ethical fashion.

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.