Investigation & Client Quality Specialist

Italy

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Not SpecifiedCompensation

Junior (1 to 2 years)Experience Level

Full TimeJob Type

UnknownVisa

Life Sciences, Pharmaceuticals, BiotechnologyIndustries

Requirements

Candidates should possess proven experience in quality management and investigation processes, strong collaboration skills to work with Compliance colleagues and support various functions, the ability to generate detailed reports related to quality events, excellent communication skills to provide customer support and train personnel, competence in preparing QATs and negotiating quality sections of contracts, and expertise in handling GMP batches and supporting Readiness and BU processes.

Responsibilities

The Investigation & Client Quality Specialist will manage Deviations and Investigations related to quality issues of batches for clinical and commercial use, coordinate the CAPA system stemming from quality investigations, support the preparation of periodic quality trends for Management and Corporate dissemination, actively participate in Operational Excellence initiatives and projects, review and manage Deviations and Investigations with other company functions to determine root causes and implement corrective actions, ensure the efficiency of corrective actions over time, collaborate in coordinating technical and management meetings with clients, and participate in client visits, quality inspections, and regulatory audits.

Skills

Quality Management

Investigation Processes

CAPA System

Root Cause Analysis

Corrective Actions

Regulatory Audits

Client Communication

Data Reporting

Operational Excellence

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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