Quality Specialist I at Thermo Fisher Scientific

São Paulo, State of São Paulo, Brazil

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Not SpecifiedCompensation

Junior (1 to 2 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Biotechnology, ManufacturingIndustries

Requirements

Adherence to all Good Manufacturing Practices (GMP) Safety Standards
Knowledge of good manufacturing, distribution, clinical, and documentation practices (GxP)
Familiarity with client requirements and regulatory standards
Ability to perform in an office environment with standard Mon-Fri schedule

Responsibilities

Provide support to quality assurance and quality inspection processes to comply with company quality policies
Adhere to good manufacturing, distribution, clinical, and documentation practices, and client requirements
Guarantee the accurate implementation of operational processes as established in current procedures
Perform local procedures updates based on Global and regional procedures
Lead GxP trainings distribution via LMS system and/or classroom
Handle issuance, revision, obsolescence, and archival of Quality documentation
Support validation, qualification, maintenance, and calibration of equipment and GxP areas
Complete and follow up on self-inspection audits
Provide support in Quality Control activities such as physical inspection and batch release of receipts
Support client, regulatory, and corporate audits
Provide Quality follow-up and revision/approval in Deviations, Complaints, CAPAs, and Change Controls
Ensure the accurate execution of operational processes
Perform quality documents translation to local language
Develop all activities in a safe and efficient manner

Skills

Key technologies and capabilities for this role

GMPGxPQuality AssuranceQuality InspectionAuditsCAPADeviationsChange ControlsValidationCalibrationLMSBatch ReleaseSelf-Inspection

Questions & Answers

Common questions about this position

Is this a full-time position?

Yes, this is a full-time position.

What is the work schedule for this role?

The work schedule is standard Monday through Friday.

What are the main responsibilities of the Quality Specialist I?

Responsibilities include supporting quality assurance and inspection processes, adhering to GMP and other practices, updating procedures, leading GxP trainings, handling quality documentation, supporting audits and validations, and managing deviations, complaints, CAPAs, and change controls.

What is the work environment like for this position?

The role involves adherence to all Good Manufacturing Practices (GMP) Safety Standards and is performed in office and GMP environments, with all activities developed in a safety and efficiency manner.

What skills or experience make a strong candidate for this role?

Strong candidates will have experience in quality assurance, GMP/GxP compliance, audit support, documentation management, and handling deviations, CAPAs, and change controls, along with the ability to lead trainings and ensure operational processes.

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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