Associate QA Officer at Thermo Fisher Scientific

Brisbane, Queensland, Australia

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Not SpecifiedCompensation

Junior (1 to 2 years)Experience Level

Full TimeJob Type

UnknownVisa

Biopharmaceutical, ManufacturingIndustries

Requirements

Tertiary education in science or engineering-based field (i.e. biopharmaceutical manufacture, biotechnology, process technology) or relevant validated experience
Previous experience in the pharmaceutical industry
Good knowledge of cGMP
Desire to work in a highly dynamic, frequently changing environment with a wide variety of people and perspectives
Flexible and adaptable attitude
Strong written, verbal and interpersonal communication skills
Strong collaborative skills with the ability to build rapport with internal and external customers
Adhere to OHS policies and procedures and ensure a safe and healthy workplace environment
Adhere to the Chain of Responsibility obligations under the Australian Heavy Vehicle National Law

Responsibilities

Drafting article code forms
Complete change notification impact assessments; draft and approve change notification change controls
Assist in activities within the quality agreement system
Assist in regulatory and client audits from readiness activities through to engagement
Building and maintaining effective working relationships with key internal collaborators from other teams and departments that foster a collaborative work environment
Participate in implementing continuous improvement (PPI) initiatives that realise cost savings and drive efficiency
Updating SOP’s and other documents to meet current regulatory and corporate standards
Ownership of quality records including but not limited to deviations, CAPAs, Audit findings etc as required
Participate in global projects and initiatives related to the remit of the Materials Management Team, as required
Perform any other legitimate duties as required by the Materials Management Team Leader

Skills

GMP

TGA

FDA

EMA

ICH

Change Control

Quality Agreements

Regulatory Audits

SOP

CAPA

Deviations

Continuous Improvement

PPI

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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