QA Auditor II at Thermo Fisher Scientific

Middleton, Wisconsin, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

NoVisa

Biotechnology, Pharmaceuticals, Clinical Research, Laboratory ServicesIndustries

Requirements

Bachelor's degree or equivalent and relevant formal academic/vocational qualification
Previous QA experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years)
In some cases, an equivalency consisting of a combination of appropriate education, training, and/or directly related experience
Proven experience in conducting internal and external audits
Knowledgeable of quality assurance processes and global regulatory guidelines
Ability to identify and assess quality and compliance issues
Outstanding problem-solving skills to determine root causes and develop solutions
Experience in technical document review and GxP activities
Strong communication skills for reporting and collaboration
Ability to successfully implement strategies and deliver quality services
Must be legally authorized to work in the United States without sponsorship
Must be able to pass a comprehensive background check, which includes a drug screening

Responsibilities

Conduct complex internal and external audits to ensure compliance with established quality assurance processes and standards
Ensure adherence to global regulatory guidelines and client contractual obligations
Identify issues impacting quality and regulatory compliance
Support the determination of root causes of non-conformance and assist in developing strategies to address these issues
Perform technical document reviews and other GxP activities in support of project work or company processes
Provide completed audit reports to management
Plan and deliver billable quality services for clients and projects

Skills

Key technologies and capabilities for this role

GMPQA AuditingQuality AssuranceBackground CheckDrug Screening

Questions & Answers

Common questions about this position

Is this a remote position or onsite?

This is a fully onsite role based at our BioAnalytical Laboratory in Middleton, WI.

What is the salary range for the QA Auditor II position?

This information is not specified in the job description.

What education and experience are required for this role?

A Bachelor's degree or equivalent and relevant formal academic/vocational qualification is required, along with previous QA experience that provides the knowledge, skills, and abilities to perform the job.

What does a typical day look like for a QA Auditor II?

A typical day involves conducting complex internal and external audits to ensure compliance, identifying quality and regulatory issues, supporting root cause analysis, performing technical document reviews, and providing audit reports to management.

What are the application requirements for this position?

Applicants must be legally authorized to work in the United States without sponsorship, able to pass a comprehensive background check including drug screening, and responsible for any relocation costs as assistance is not provided.

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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