QC Micro Specialist II at Thermo Fisher Scientific

Ferentino, Latium, Italy

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, BiotechnologyIndustries

Requirements

Degree in Biology/Biotechnology or Technical Biology Diploma with proven experience
Knowledge of common analytical techniques and instrumentation
Solid experience and knowledge of company flows and organization
Knowledge of company procedures and GMP
Knowledge of statistics
Basic microbiological knowledge
3-5 years of experience in QC Microbiological laboratory in pharmaceutical company or similar
Experience in analysis laboratory or pharmaceutical technique laboratory
Fluent English
Flexibility
Good organizational and planning skills
Listening and communication skills
Ability to work in a team

Responsibilities

Control the correct execution of analyses and insertion of analytical data into laboratory notebooks and raw validation data
Review microbiological data and intercept any issues found during review
Draft validation protocols and reports and analytical methods at the end of validation
Check the status of training and materials necessary for validation execution
Perform necessary analytical activities in own area
Control the correct management of analytical documentation, from receipt to control, archiving, and traceability, both internal and external, according to procedures and company quality standards
With delegation from the Team Leader, ensure the issuance, verification, and transfer of microbiological analytical results in compliance with procedures and company standards
Contribute to optimal execution of analyses through adequate technical training of laboratory personnel during onboarding and introduction of new methods, in compliance with company standards
Support the team in continuously updating procedures in the area of expertise through drafting and review based on needs, in compliance with regulations, laws, and GMP
Control compliance with company quality standards through timely review of related documentation and oversight of procedure application in areas of expertise, respecting company quality policies and procedures on Data Integrity and Compliance
Participate in project calls and drafting of analytical protocols and reports
Evaluate project CCs
Provide support during regulatory inspections

Skills

Microbiological Analysis

GMP

Data Review

Validation Protocols

Laboratory Documentation

Quality Control

Training

SOP Writing

Analytical Methods

QA Collaboration

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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