Thermo Fisher Scientific

QC Analytical Data Reviewer, Pharma - Remote

Ireland

Not SpecifiedCompensation
Mid-level (3 to 4 years)Experience Level
Full TimeJob Type
UnknownVisa
Pharmaceuticals, Biotechnology, Life SciencesIndustries

Requirements

Candidates must possess a Bachelor's degree or equivalent formal academic qualification, with a minimum of 2 years of laboratory analytical experience utilizing chemistry analytical techniques and proven experience reviewing analytical data. Experience in chromatography, Empower, HPLC, and dissolution is required, along with thorough knowledge of SOPs, Federal Regulations (GLP, GMP), and divisional SOPs. Strong technical knowledge of laboratory procedures, methodology, and standards is essential. Candidates must also possess strong verbal and written communication skills, a strong attention to detail, and the ability to train staff, independently review reports and methods, manage multiple priorities, provide clear feedback, and work collaboratively in a team environment. The ability to communicate effectively, work upright and stationary/standing for typical hours, lift up to 25 pounds, work in non-traditional environments, and use standard office technology proficiently is also required.

Responsibilities

The QC Analytical Data Reviewer will monitor the quality of laboratory data and reports, including chromatographic data and related notebooks, in accordance with Standard Operating Procedures. They will evaluate laboratory data for compliance with analytical methods and SOPs, review sample results for completeness and accuracy, and report findings. The role involves communicating with laboratory staff to address documentation quality, preparing QC statements for deficiencies, and reporting these to the project leader. Additionally, the reviewer will train new QC Reviewers and laboratory staff, conduct SOP review and writing, perform consultations for quality records, and undertake other assigned duties.

Skills

Data Review
Analytical Methods
SOPs
Chromatographic Data
GMP
Quality Control
Laboratory Data

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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