QA Auditor I - Ireland (Athlone)

Ireland

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Biotechnology, Clinical ResearchIndustries

Requirements

Candidates should possess a Bachelor's degree or equivalent and have 3-5 years of relevant QA or lab experience. Proficiency in GxP and regional regulations is necessary, along with demonstrated ability to conduct GxP audits based on SOPs, FDA regulations, and ICH guidelines. Strong skills in reviewing study documents for regulatory compliance, excellent oral and written communication, problem-solving, risk assessment, negotiation, and conflict management are also required.

Responsibilities

The QA Auditor will audit laboratory data for compliance with methods and SOPs, reporting any findings. They will also audit sample result tables and analytical reports for completeness and accuracy, reporting findings as well. The role involves serving as a resource for operational departments on quality assurance matters and assisting in the preparation of audit findings and related information.

Skills

QA Auditing

GxP

FDA regulations

ICH guidelines

SOPs

Laboratory Data Auditing

Analytical Reports

Quality Assurance

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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