Quality Assurance Specialist II

Thermo Fisher Scientific; São Paulo; Híbrido; BRL 70.000 - 90.000; Tempo integral

Resumo da oferta

A leading company in the life sciences sector is seeking a Quality Assurance professional to ensure compliance with manufacturing and quality standards. The role involves supporting quality control activities, leading training sessions, and managing documentation. The position offers a hybrid work model, requiring three days in the office and two days at home, with a focus on safety and efficiency.

Qualificações

• Advanced or fluent English is mandatory.

Responsabilidades

• Support Quality Assurance and Quality Control compliance.
• Lead GxP training sessions.
• Conduct self-inspection audits and supplier assessments.

Conhecimentos

Quality Assurance

Quality Control

Compliance

GxP

English

Descrição da oferta de emprego

Work Schedule

Flex Shifts, 40 hrs/week.

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) and Safety Standards. Office environment, some PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs, etc.), Warehouse.

Job Description

1. Provide support to Quality Assurance and Quality Control to ensure compliance with good manufacturing, distribution, clinical, and documentation practices.
2. Issue updates to local procedures based on global procedures, local regulations, and operational requirements.
3. Lead GxP training sessions, distributed via LMS system and/or classroom.
4. Manage issuance, revision, obsolescence, and archival of quality documentation following GxP and ALCOA principles.
5. Participate in validation, qualification, maintenance, and calibration of equipment and GxP areas.
6. Conduct and follow up on self-inspection audits, supplier assessments, audits, qualifications, and the elaboration of Quality Technical Agreements.
7. Support Quality Control activities such as physical inspections, batch releases in quality systems (GPM and CTWin), and inspection and release of shippers and materials.
8. Follow up on Deviations, Complaints, and CAPAs.
9. Ensure the accurate execution of operational processes.
10. Develop all activities with a focus on safety and efficiency.

Advanced or fluent English is mandatory.

Availability to work at Jaguaré - São Paulo/SP.
Hybrid work model: 3 days in the office, 2 days at home.