Lead QA Technician

at  Thermo Fisher Scientific

JOB DESCRIPTION

Job Title: Lead QA Technician (Investigations Specialist)
Requisition ID: R-01229707
When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.

KNOWLEDGE, SKILLS, ABILITIES

• English (Speaking and writing fluent)
• Italian Fluent
  At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer. Apply today! http://jobs.thermofisher.com
  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.

Manages Deviations, Investigations relevant to quality issues impacting batches manufactured for clinical and commercial use, by ensuring their completion within the expected timelines;
Manages the CAPAs resulting from quality investigations;
Supports the preparation of periodic quality trends, intended for Management and Corporate visit;
Manages non-conformities in receiving raw materials, active ingredients and GMP materials (incoming defects).
Supports and actively participates in initiatives/projects with Operational Excellence;
Actively participates in all meetings established for new and ongoing projects by taking care quality topics;
Examines and verify and manages Deviations and Investigations with several functions to define the causes and implement the corrective action plan within the timelines established by technical agreements;
Collaborates with DPS (Commercial division) colleagues in organizing technical and management meetings with customers;
Participates in customer visits and quality inspections (Audit);
Generates reports regarding DPS quality events (quarterly monitoring);
Contributes to the achievement of quality objectives for the part under his responsibility, and of the RFT, Deviation Rate, Past due, Ontime closure objectives;
Collaborates with Quality System colleagues in reviewing the SOPs that fall within the scope of the DPS;
Provides customers with TLC and email support by promptly responding to quality questions;
Carries out training of staff involved in quality compliance activities for DPS;
Participates in the drafting of Risk Assessment;
Supports and executes negotiation of Quality Technical Agreements with Customers