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Job Title:  Quality Supervisor

Req ID:  19228
Job Category:  Quality
Country/Region:  IT
State:  BG
City:  Seriate
Zip:  24068
Description: 

Laboratory QA Supervisor

 

Target Salary € 35.000=

 

MINIMUM REQUIREMENTS AND SKILLS

 

1. Bachelor's degree in a science

2. Minimum 3 vears of experience in Laboratories activities

3. Working knowledge in ISO 13485, ISO 17025 and quality management

4. High school level of English reading, writing and verbal communication skills

5. Driver license minimum B level

6. Travel 5%

7. Team work attitude

8. Knowledge in Microsoft Office applications (Word Excel, Access and Power Point).

9. Flexibility to work additional hours, when needed to support short term needs

10. Maintain good relationships with the LAB, QA team, co-workers and processing facilities.

Header
Position Summary
Duties
Duties - cont'd
Education Degree
    Required Experience

     

    Principal Duties and Responsibilities:

     

    1. Work in collaboration with the Lab Manager and the Lab Tech Team as the main resource and point of contact for lab quality support.

    2. Ensure Quality System complies with STERIS procedures, standards and applicable laws

    3. Comply with STERIS Health and Safety Policies

    4. Initiate, investigate, control and analyze non-conformance reports ensuring all relevant parties are informed and where appropriate, to ensure corrective action, in collaboration with all departments involved, and implemented effectively.

    5. Initiate, investigate, control and analyze the recording and investigating of customer complaints. Execute corrective actions, in collaboration with all departments involved, is implemented and that it is effective

    6. Support OOS (Out of Specifications) reports ensuring all relevant parties are informed and where appropriate, to ensure corrective action, in collaboration with all departments involved, is implemented and that it is effective

    7. Facilitate Audits (Regulatory Inspections, Customer Audits, Supplier Audits) in collaboration with LAB Manager. Ensure that the internal audit program is executed as per plan and perform audits as required

    8. Identify and report any failures in the implementation of the quality system to the Italy Quality Regional Manager, Lab Quality Zone Director and LAB Manager. Investigate such matters and recommend appropriate corrective action

    9. In conjunction with operations via the formalized change management process ensure all new equipment/instruments and quality related software are qualified and requalified either periodically or after modification prior to use

    10. Undertake projects in collaboration with Italy Quality Regional Manager, Lab Quality Zone Director and LAB Manager and adhere to formalized change management processes

    11. Implement continuous improvement activities in agreement with Quality Zone Director and LAB Manager

    12. Monitor Laboratories performance through facilitation of quarterly facility management review.

    13. Facilitate Quality and GMP training of all Laboratory personnel; develop, support and maintain the LAB Employee Training Program.

    14. Review technical documents related to Technical Services, Process Validation, Cleaning Validation, Product Specifications, Test methods, Quality and Technical Agreement with the supplier.

    15. Review Customer Quality Agreements.

    16. Provide and maintain service excellence to Customers; provide professionalism and courtesy at high level; attend meetings with the Customers

    17. To undertake any other such duties as may become necessary, and as may reasonably be expected, in the provision of the quality assured service, in collaboration with Italy Quality Regional Manager, Lab Quality Zone Director and LAB Manager

    18 As part of the Seriate facility quality department, provide quality support and backup as needed to the ebeam operations facility.