Quality Assurance Specialist II

Thermo Fisher Scientific Inc.; Marietta (OH); Hybrid; USD 60,000 - 80,000; Full time

Job summary

A leading company in the life sciences field is looking for a Quality Assurance Support specialist in Marietta, Ohio. The role entails ensuring compliance with good manufacturing practices, supporting Quality Control activities, and handling quality documentation. The ideal candidate will have strong knowledge in quality assurance, be fluent in English, and be committed to safety and efficiency in all operations.

Qualifications

• Advanced / Fluent English is mandatory.
• Experience in GxP environments.

Responsibilities

• Provide support to Quality assurance and Quality control.
• Handle issuance, revision, and archival of quality documentation.
• Participate in validation and calibration of equipment.

Skills

Quality Assurance

Quality Control

GxP Training

Documentation

Problem Solving

Safety Practices

Job description

Work Schedule

Flex Shifts 40 hrs/wk

Environmental Conditions

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

Job Description

• Provide support to Quality assurance and Quality control in order to accomplish with good manufacturing, distribution, clinical and documentation practices.
• Issue local procedures updates based on the global procedures, local regulations and operational requirements.
• Lead GxP trainings distribution via LMS system and/or classroom.
• Handle issuance, revision, obsolescence and archival of quality documentation based on GxP and ALCOA principles.
• Participate on validation, qualification, maintenance and calibration of equipment and GxP areas.
• Complete and follow up on self-inspection audits of supplier assessments, audits, qualification and elaboration of Quality Technical Agreement.
• Provide support in Quality Control activities such as physical inspection and batch release of receipts in quality system (GPM and CTWin), shippers and materials inspection and release.
• Quality follow up in Deviations, Complaints and CAPAs.
• Ensure the accurate execution of operational processes.
• Development of all activities with safety and efficiency manner!

Advanced / Fluent English is mandatory

Availability to work at Jaguaré - São Paulo/SP
Hybrid: 3x at the office, 2x at home