QC Scientist - Biochemistry at Thermo Fisher Scientific

Brisbane, Queensland, Australia

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

BiopharmaceuticalIndustries

Requirements

Bachelor of Science or equivalent experience in Biotechnology, Biochemistry, or a related field (Post Graduate qualifications 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 desirable)
Demonstrated capability to operate autonomously and collaboratively within a team
Ability to effectively communicate in multiple modalities (e.g. electronic, written, verbal)
Proficient in Smartsheets, Microsoft Word, Excel, and PowerPoint
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 (e.g., 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

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 (e.g. failure mode effect analysis, fishbone diagrams, hazard and operability studies) and advise others on their application
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
Ensure 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)

Skills

ELISA

Endotoxin

UV-VIS

SoloVPE

qPCR

GMP

TGA

analytical development

qualification protocols

validation protocols

batch release

stability testing

CAPA

OOS

OOT

risk assessments

FMEA

Thermo Fisher Scientific

Provides life sciences products and services

About Thermo Fisher Scientific

Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.

Waltham, MassachusettsHeadquarters

1956Year Founded

$17MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Increased competition in single-use bioprocessing may impact market share.

Sale of anatomical pathology business could create a temporary product gap.

Investment in miDiagnostics may face regulatory challenges affecting returns.

Differentiation

Thermo Fisher offers a comprehensive range of life sciences products and services.

Their well-known brands include Thermo Scientific, Applied Biosystems, and Invitrogen.

They provide strong customer support and educational resources to optimize client workflows.

Upsides

Expansion of biologics production facility enhances capacity for precision biologics monitoring.

Investment in miDiagnostics aligns with demand for rapid diagnostic solutions in BioPharma.

Collaboration with Mainz Biomed positions them in the growing cancer detection market.

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