QC Scientist at Thermo Fisher Scientific

Brisbane, Queensland, Australia

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, BiotechnologyIndustries

Requirements

Have 3-5 years of GMP experience
Have client-facing experiences, able to confidently manage client's expectations
Have strong analytical skills and analytical document (such as protocols and reports) writing experience
Good at communication in-person, via teleconferences, and through e-mails
Attend to details and able to work in fast-paced environment

Responsibilities

Serve as a 12-month contracted replacement for an employee on leave
Act as a customer-facing QC representative for specific projects: present QC scope to clients in kick-off meetings, independently liaise with clients on standard work scope, confidently handle client queries, expectations, and challenges, and support QC planning by supplying and updating relevant dates
Author QC-specific batch documentation including Sampling Plans, specification documents, qualification and validation protocols and reports in line with Patheon policies and regulatory guidelines; review protocols, data, and reports
Prepare data in support of specification discussions and facilitate specification council meetings
Investigate and evaluate new methods/techniques, judge their scientific soundness, and decide on feasibility of implementation at the Patheon Brisbane site
Independently initiate and handle change control activities ensuring adherence to cGMP and EH&S guidelines
Liaise with QC laboratory teams to draft test methods; support QC laboratory teams in developing relevant test methods; assist QC laboratory team members with execution of analytical studies and troubleshooting method performance
Work directly with program management teams to ensure analytical contractual stages and timelines for customer projects are met
Work directly with program management teams to ensure customer satisfaction and expectations are maintained in the most profitable way
Monitor new technologies relevant to the QC department that may offer more cost-effective and robust solutions
Ensure the scientific integrity of QC teams is maintained, working closely with the data integrity officer
Facilitate atypical, out of specification, or out of trend investigations with the team for swift resolution and recommend appropriate resolutions
Apply various risk assessment tools (e.g., failure mode effect analysis, fishbone diagrams, hazard and operability studies) and develop, participate in, and advise on their appropriate and efficient application
Apply the Quality System, Change Control, Deviations, CAPA, OOS and OOT, Document Management related to the Quality Control Department
Assist with PPI projects
Perform any other legitimate duties as directed by the Senior Manager, QC (or delegate)

Skills

cGMP

Validation Protocols

Sampling Plans

Specification Documents

Change Control

Test Methods

Analytical Studies

Data Integrity

Regulatory Guidelines

EH&S

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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