Investigation & Client Quality Specialist 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

Life Sciences, Pharmaceuticals, BiotechnologyIndustries

Requirements

Bachelor’s degree in Pharmacy, Chemistry, Biology, Biotechnology, or a related scientific field
Minimum 2 years of experience in a similar role
Strong knowledge of GMP/GDP principles and pharmaceutical quality systems
Experience in complaint handling, investigations, or quality assurance within the pharmaceutical industry
Excellent analytical and problem-solving abilities; ability to perform structured root cause analysis
Strong written and verbal communication skills in English
Ability to collaborate across multiple departments and manage multiple cases simultaneously

Responsibilities

Handles deviations and investigations (including complaints and non-conformities in receipt of raw materials, active ingredients, and GMP materials) related to quality issues in batches manufactured for clinical and commercial use, ensuring completion within the encouraged timeframes
Leads the CAPA system resulting from quality investigations
Supports the preparation of periodic quality trends for management and corporate dissemination
Supports and contributes to Operational Excellence initiatives/projects
Actively participates in all meetings scheduled for new and ongoing projects
Analyzes and coordinates discrepancies and inquiries across different company departments to identify the root causes and implement the corrective action plan within the timelines set by technical agreements
Verifies the efficiency of corrective actions over time
Collaborates with colleagues in coordinating technical and management meetings with customers
Participates in customer visits and quality inspections (audits), as well as internal and regulatory quality inspections
Generates reports on quality events
Contributes to the achievement of quality objectives for their area of responsibility, as well as RFT, Deviation Rate, Past Due, and Ontime Closure objectives
Contributes to the achievement of business/customer happiness objectives
Collaborates with Compliance colleagues in reviewing and drafting Quality System SOPs that fall within the scope of their Quality Unit
Provides customer support via telecommunications and email, responding promptly to quality questions
Contributes to the development of FMEAs
Manages the drafting, archiving, and distribution of controlled company documentation
Provides training to personnel involved in PDS/DPS quality activities
In accordance with the manager’s instructions and activity scheduling, leads all aspects of the drafting of QATs and their negotiation with customers, site QPs, and legal counsel
Serves as SME and QO contact for assigned projects, representing the quality point of reference and support for customers and internal departments to ensure the success of projects and the manufacturing/disposition of GMP batches
Supports the team and other functions in ensuring full support for Readiness and Business Unit processes

Skills

Key technologies and capabilities for this role

Root Cause AnalysisCAPAGMPQuality InvestigationsDeviationsNon-ConformitiesRegulatory ComplianceContinuous ImprovementOperational ExcellenceClient Relationship Management

Questions & Answers

Common questions about this position

What is the work schedule and location for this role?

This is a full-time position with a standard Monday-Friday schedule in an office environment.

What are the main responsibilities of the Investigation & Client Quality Specialist?

The role involves investigating client complaints and deviations, leading CAPA systems, implementing corrective actions, supporting quality trends and Operational Excellence initiatives, and collaborating on customer meetings and audits.

What skills or experience are required for this position?

Key skills include expertise in handling deviations, investigations, and CAPA systems in GMP environments, root cause analysis, regulatory compliance, collaboration with customers and departments, and experience with quality audits and SOPs.

Is this a remote position, or is office work required?

The position is based in an office environment with no mention of remote work options.

What makes a strong candidate for this role?

Strong candidates will have experience in quality investigations, CAPA leadership, GMP compliance, root cause analysis, and customer collaboration in a regulated manufacturing environment, along with the ability to lead projects and participate in audits.

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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