Investigation & Client Quality Specialist

ThermoFisher Scientific; Ferentino; On-site; EUR 45,000 - 65,000; Full time

Job summary

Thermo Fisher Scientific is seeking a Quality Assurance specialist to join our office-based team in Italy. You will ensure product quality and regulatory compliance in a GMP environment, reviewing documentation, and supporting internal and external audits.

Ideal candidates hold a Bachelor's degree and have experience in pharmaceutical sterile, medical devices or regulated industries, with strong knowledge of cGMP, ISO standards, and QA systems like TrackWise or SAP.

Qualifications

• Bachelor's degree required; experience in sterile pharma or regulated industry preferred.

Responsibilities

• Ensure product quality and regulatory compliance in GMP environment.

Skills

Quality systems

cGMP knowledge

Root cause analysis

Documentation review

TrackWise

SAP

Analytical skills

Cross-functional

Italian & English

Education

Bachelor's degree

Chemistry/Biology/Engineering

Tools

TrackWise

SAP

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.

DESCRIPTION:

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.