R&D QUALITY SPECIALIST

17 ore fa

Ferentino FR, Provincia di Frosinone; Lazio, Italia Altro Tempo pieno
Work Schedule Standard (Mon-Fri) Environmental Conditions Office 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. Bachelor's Degree required, prior experience preferred. Experience in pharmaceutical sterile, medical device or regulated industry preferred 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.) 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 Experience with continuous improvement methodologies (Lean, Six Sigma) preferred 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.