Data Reviewer - HPLC, GMP

Wisconsin, United States

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Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

Biotechnology, Pharmaceuticals, Life SciencesIndustries

Requirements

Candidates should possess a Bachelor's degree or equivalent qualification and at least 2 years of relevant experience. A strong understanding of laboratory procedures, methodology, and standards is required, along with excellent attention to detail and communication skills. Demonstrated knowledge of HPLC is strongly preferred, as is previous experience in a GMP lab and with chromatographic review using Empower. A thorough knowledge of SOPs and Federal Regulations, including GLP and GMP, is also necessary.

Responsibilities

The Data Reviewer will evaluate laboratory data for compliance with analytical methods, client directives, and SOPs, ensuring scientific soundness and accuracy. They will review sample results, communicate with laboratory staff to maintain documentation quality, and deliver findings on deficiencies. The role involves escalating significant deficiencies, facilitating discussions on best practices, advocating for quality improvements, and identifying process improvement initiatives. Other assigned duties may also be performed.

Skills

HPLC

GMP

Data Review

Analytical Procedures

SOPs

Quality Control

Pharmaceutical Analysis

Biopharmaceutical Analysis

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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