Quality Control Specialist - Categoria Protetta

Job Summary

The Quality Control Specialist executes the incoming inspection of raw materials (chemicals and packaging) and the quality control activities on intermediates and finished products in accordance with the indications of the Technical Documentation and the Quality System procedures.

He/she performs a variety of routine and specialized laboratory testing, analyzes the data and prepares reports on the results achieved.

Key Accountabilities

• Performs sampling of raw materials, intermediates and finished products in accordance with the required sampling plan.
• Performs routine laboratory tests and the value assignment activities.
• Compiles experimental data performs calculations and prepares graphs to present and discuss with the QA/QC Manager.
• Prepares Certificate of Analysis of raw materials and finished products for their review and discussion with the QA/QC Manager.
• Performs specialized laboratory testing related to validations, stability studies, VEQ programs, complaint investigations, internal non-conformities and CAPAs.
• Takes care that all data is accurately recorded in accordance with guidelines and laboratory procedures.
• Assists the QA/QC Manager to prepare and update the applicable technical documentation and the appropriate Quality System procedures.
• As Originator, creates Change Orders in the corporate information system (SAP).
• Performs routine equipment and laboratory maintenance.
• Maintains a clean and sanitary work area in accordance with standard laboratory practice and procedures.
• Applies the laboratory procedures related to quality, safety, and environment.

Networking/Key relationships

• Quality Engineering
• Product Development
• Documentation Control
• All Department of the Werfen Manufacturing Center of Ascoli Piceno
• Clinical Chemistry SBU

Minimum Knowledge & Experience required for the position

Education: Master's Degree in a scientific discipline (CTF, Chemistry, Biomedical Engineering, Biology) or equivalent professional experience.

Experience: at least 1 years of work experience in the functions of Quality Control

(IVD, MD, pharmaceutical sectors are preferred).

Additional Skills/Knowledge:

• Good technical skills in laboratory practice.
• Ability to learn specific, practical techniques and apply this knowledge to solve technical problems.
• Ability to maintain, calibrate and use technical equipment with accuracy.
• Familiarity with basic software tools (Excel, Word); knowledge of SAP.
• Good English knowledge (spoken and written).

Skills & Capabilities

• Ability to work independently with moderate guidance
• Accurate recor d keeping and notebook skills
• Analytical skills
• Attention to details
• Flexibility
• Team working
• Proactivity

Travel requirements

5% of time