[Remote] Labs Data Reviewer (GMP, Biopharmaceutical) at Thermo Fisher Scientific

Wisconsin, United States

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Not SpecifiedCompensation

N/AExperience Level

N/AJob Type

Not SpecifiedVisa

N/AIndustries

Requirements

Bachelor's degree or equivalent and relevant formal academic / vocational qualification
2+ years of experience
Legally authorized to work in the United States without sponsorship
Ability to pass a comprehensive background check, which includes a drug screening
Demonstrated experience of HPLC data review strongly preferred
Previous experience with in GMP regulated laboratory environment strongly preferred
Thorough knowledge of SOPs and Federal Regulations to include GLP and GMP
Thorough knowledge of chromatography

Responsibilities

Evaluates laboratory data for compliance with analytical methods, client directives, and SOPs
Reviews sample results for scientific soundness, completeness, accurate representation of the data, and final reported results
Communicates with laboratory staff to proactively maintain the quality of laboratory documentation
Delivers review findings noting deficiencies within the analytical data or reports in a clear and concise manner
Escalates significant deficiencies to the project leader or supervisor for assessment
Facilitates in conversations with lab staff on best documentation practices and addressing quality findings
Advocates for quality and review process changes
Identifies and supports process improvement initiatives
Performs other duties as assigned

Skills

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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