Quality Assurance Specialist

4 settimane fa

Ascoli Piceno, Marche, Italia Werfen A tempo pieno

Job Overview

At Werfen, we are seeking a highly skilled Quality Control Specialist to join our team. In this role, you will be responsible for executing the incoming inspection of raw materials and the quality control activities on intermediates and finished products. You will perform a variety of routine and specialized laboratory testing, analyze the data, and prepare reports on the results achieved.

Key Responsibilities:

  1. Sample raw materials, intermediates, and finished products in accordance with the required sampling plan.
  2. Conduct routine laboratory tests and value assignment activities.
  3. Compile experimental data, perform calculations, and prepare graphs to present and discuss with the QA/QC Manager.
  4. Prepare Certificate of Analysis of raw materials and finished products for review and discussion with the QA/QC Manager.
  5. Perform specialized laboratory testing related to validations, stability studies, VEQ programs, complaint investigations, internal non-conformities, and CAPAs.
  6. Maintain accurate records of all data in accordance with guidelines and laboratory procedures.
  7. Collaborate with the QA/QC Manager to prepare and update technical documentation and Quality System procedures.
  8. Perform routine equipment and laboratory maintenance.
  9. Ensure a clean and sanitary work area in accordance with standard laboratory practice and procedures.

Networking/Key Relationships:

  • Quality Engineering
  • Product Development
  • Documentation Control
  • All Departments of the Werfen Manufacturing Center
  • 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 year 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 record keeping and notebook skills.
  • Analytical skills.
  • Attention to detail.
  • Flexibility.
  • Team working.
  • Proactivity.

Travel Requirements:
5% of time.

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