Investigation & Client Quality Specialist - Fixed Term

ThermoFisher Scientific; Ferentino; On-site; EUR 52,000 - 70,000; Full time

Job summary

Thermo Fisher Scientific is seeking a dedicated Quality Assurance professional to join our team in Italy. In a GMP environment, you will ensure product quality, support regulatory compliance, and drive continuous improvement across cross-functional teams.

Strong documentation skills and knowledge of cGMP/ISO standards are essential, along with fluent Italian and English. Travel up to 10% may be required; prior experience in regulated industries is preferred.

Qualifications

• Bachelor's degree in a scientific/technical field.
• Preferred: experience in pharmaceutical sterile, medical device or regulated industry.
• Additional certifications in Quality Systems or GMP preferred.

Responsibilities

• Ensure product quality and regulatory compliance in a GMP environment.
• Drive continuous improvement initiatives across cross-functional teams.
• Support internal quality audits and external regulatory audits.

Skills

Quality assurance

GMP compliance

Quality systems

Documentation review

Root cause analysis

Cross-functional collaboration

Audits

Lean Six Sigma

Communication (Italian/English)

Education

Bachelor's Degree

Chemistry

Biology

Biotechnology

Engineering

Tools

TrackWise

SAP

MS Office

Job description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer. At Thermo Fisher Scientific, you'll join a quality assurance team focused on ensuring consistent execution of quality standards and regulatory compliance. You'll play a vital role in enabling our customers to make breakthrough discoveries and innovations that make the world healthier, cleaner and safer. You'll ensure product quality, drive continuous improvement initiatives, and collaborate with cross-functional teams to maintain the highest standards of quality and compliance in a GMP environment.

Requirements

• Bachelor's Degree required, prior experience preferred. Experience in pharmaceutical sterile, medical device or regulated industry preferred
• Preferred Fields of Study: Chemistry, Biology, Biotechnology, Engineering, or related scientific/technical field
• Additional certifications in Quality Systems or GMP preferred
• Strong knowledge of cGMP, ISO standards (13485/9001), and international regulatory requirements
• Experience with quality systems and documentation including batch records, SOPs, deviations, CAPA
• Proficiency in quality management software systems (TrackWise, SAP, etc.)
• Demonstrated ability to perform detailed documentation review and quality assessments
• Strong analytical and problem-solving skills for quality investigations and root cause analysis
• Excellent written and verbal communication skills both Italian and English
• Ability to work independently and collaborate effectively with cross-functional teams
• Experience conducting internal quality audits and supporting external regulatory audits
• Proficient computer skills including Microsoft Office applications
• Strong attention to detail and commitment to accuracy
• Ability to prioritize and adapt in a changing environment
• Experience with continuous improvement methodologies (Lean, Six Sigma) preferred
• May require up to 10% travel
• Must be able to work in controlled environments wearing required PPE
• Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.