Quality on the Floor Specialist at Thermo Fisher Scientific

Monza, Lombardy, Italy

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Not SpecifiedCompensation

Junior (1 to 2 years), Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Biotechnology, ManufacturingIndustries

Requirements

Adherence to Good Manufacturing Practices (GMP), Safety Standards, and Cleanroom protocols (no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair, etc.)
Knowledge of company procedures, quality standards, and applicable regulations (GMP laws, FDA, etc.)
Ability to work rotational days/weekends in office and production environments

Responsibilities

Perform Batch Record Review for GMP batches, ensuring compliance with company procedures, quality standards, and regulations (sterile, sperlatura, and packaging sections)
Manage qualitative issues impacting production (commercial batches, process validation batches, Media Fill batches), including decision-making and coordination
Conduct periodic and extraordinary quality surveillances (Overlooking, GEMBA walks, Fit & Finish) to promote housekeeping and proactively diffuse Quality Culture in departments
Perform preliminary investigations of deviations by drafting "Rapid" documents for client notifications and gathering initial information
Open deviation events using GMP software (Trackwise)
Collaborate with Quality Operations and Department Quality Specialists for investigations, root cause analysis, and identification of corrective/preventive actions (CAPA)
Approve GMP production parameters (equipment, software, machine recipes, product serialization data entry)
Execute GMP-related activities for process improvements, controls, evaluations, and corrections (Action Items, CAPA)
Analyze client comments on commercial batch documentation and prepare responses
Handle minor modification requests (RMM) to work instructions (BR) for continuous improvement (typos, system errors, operational description changes)
Participate in Continuous Improvement with Production and PPI Team, supporting new workflows, procedure optimization, and PPI tools
Train personnel in Quality on the Floor activities and department operations related to area of competence, per company procedures
Support Team Leader in updating SOPs for area of competence by drafting necessary documentation in compliance with GMP
Provide and authorize distribution of compliant copies in collaboration with Master Batch Record function, as needed

Skills

Key technologies and capabilities for this role

GMPBatch Record ReviewQuality AssuranceDeviation ManagementTrackwiseGemba WalkHousekeepingQuality CultureFDA RegulationsMedia FillRapid Investigation

Questions & Answers

Common questions about this position

What is the work schedule for this position?

The work schedule is rotational days/weekends.

Is this a full-time position?

Yes, this is a full-time employment opportunity.

What are the main responsibilities of the Quality on the Floor Specialist?

The role involves Batch Record Review of GMP batches, qualitative management of production activities, conducting quality surveillances, handling deviations, investigations, CAPAs, and promoting Quality Culture through GEMBA walks and Overlooking.

What environmental conditions apply to this role?

The position requires adherence to Good Manufacturing Practices (GMP) Safety Standards in a cleanroom environment, with restrictions on hair products, jewelry, makeup, nail polish, perfume, exposed piercings, and facial hair.

What kind of experience makes a strong candidate for this role?

Strong candidates will have experience in GMP environments, batch record review, deviation management, CAPA processes, and promoting quality culture in production settings, along with familiarity with tools like Trackwise.

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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