Jobs for People with MS: National MS Society

Job Description

About us

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $44 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, improving patient diagnostics and therapies or increasing efficiency in their laboratories, we are here to support them. Our team of more than 125,000 colleagues 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

Position Summary

Manufacturing of biopharmaceutical products is required to be in compliance with international 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. Our team are responsible for ensuring the completion of qualification/validation protocols, batch release and stability testing. We are a quickly expanding site with ever growing opportunities. The role of Senior QC Technician is based in our Brisbane office. We believe our workforce are our greatest asset, and are passionate about nurturing and developing future talent!

Key Responsibilities:

• 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 within the laboratory (ELISA, Endotoxin, UV-VIS, SoloVPE and qPCR). Assessment of analysis against predefined specification. Effective execution of test records for customer requirements.

• Identify and report non-conformances and Lab Incidents/OOS/UR results directly to QC Biochemistry Team Leader or delegate.

• Peer review of analysis for completeness and correctness.

• Ensure the efficiency of the QC Biochemistry Laboratory aligns with EH&S guidelines and Quality Standards.

• Lead, mentor and motivate members of the team.

• 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.

• The Brisbane site is a multi-product biopharmaceutical site with development and manufacturing facilities for pharmaceutical products for clinical (Phase I, II and III) and commercial use.

Stakeholder Engagement

• Internal - QC, QA, Operations, Engineering, and Supply Chain staff.

Qualifications & Experience

• Degree in Science (Biotechnology / Chemistry, or similar), favourable

• Specific knowledge of Bio-pharmaceutical processes, Pharmaceutical guidelines and principals of Good Manufacturing Practice, favourable

• Proven record of ability to work as a team member and independently.

• Experience in multitasking, prioritizing and showing initiative to complete tasks according to company milestones / goal tree.

• Proficient with Microsoft Word, Excel and PowerPoint.

• Strong communication skills - both written and verbal

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.

We welcome applications from early careers candidates who have had experience of working independently within a Lab environment.

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.

We offer competitive compensation and benefits packages, along with opportunities for professional growth and development. If you are a motivated individual with a passion for demand planning and inventory management, we invite you to apply for this exciting opportunity. Watch as our colleagues explain 5 reasons to work with us (https://jobs.thermofisher.com/global/en/5-reasons-to-work-at-thermo-fisher-scientific) .

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.

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.