Investigation & Client Quality Specialist

1 giorno fa

Ferentino FR, Provincia di Frosinone; Lazio, Italia Altro Tempo pieno

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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.

Investigation & Client Quality Specialist

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