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Molecular Quality Assurance Associate

4 mesi fa

Bresso, Italia DiaSorin A tempo pieno

DiaSorin Group Standard Job Description

Job
Molecular Quality Assurance Associate

Title

Job

**Organizational Area**: Molecular Business Unit
Kind of contract

Facts

**Country / State**: Italy
- Full Time / Part Time: Full time

**Place of work**:. Gerenzano (VA). Bresso (MI) permanent location from september 2023
- Permanent / Temporary: Permanent

**Home / Office based**: Hybrid work

**Job ID**:
**Legal Entity**: DiaSorin Italia S.p.A.

**Professional Family**: Quality

**Reporting To**: Molecular Quality Assurance Specialist

Job
YOUR MISSION

Scope
Provide technical analysis of processes that are involved in the development and manufacturing of products in order to ensure that they are in compliance with quality requirements and meet specifications. Help and support such activities while ensuring that applicable standards and procedures are followed.

Participate in Project teams and representing Quality groups and ensuring that Design Control requirements are met. Support Corrective and Preventive actions and ensure that Root Cause Investigations are performed using appropriate Quality Tools. Support and ensure that validation activities are well documented and performed.

Main
YOUR CONTRIBUTIONS

**Responsibilities**:

- Ensure that appropriate procedures are established to support Design Development processes.
- Review of design and development processes and ensure that appropriate documentations are established during this process in accordance with the Design Control procedures.
- Review verification and validation activities to ensure that they are well established and compliant with the regulations.
- Review specifications, operation instructions, process procedures, test procedures, inspection and test analysis.
- Support the risk management activities for new product development including risk plans, and reports and assisting with all FMEAs to ensure compliance.
- Develop process flow diagrams and perform gap analyses on current controls/status versus required controls/status.
- Assist in corrective and preventive actions and verifications of effectiveness checks for internal and external audits.
- Perform assigned tasks in accordance with applicable Environmental Health and Safety (EHS) regulations and Company EHS policies. Violations of EHS regulations or policies will be handled in accordance with the established Company disciplinary process.
- Participate in Audits (Internal and External), and Regulatory authority inspections and ensure that risk to company is minimized as much as possible.
- Perform other duties as assigned.

**Qualifications**:
YOU

**Education / Specialization**:
Bachelor’s Degree preferred in an Engineering or life sciences discipline such as Biochemistry, Chemistry, Microbiology, Biotechnology or Bio-Engineering,

Experience

**Experience**:
2 to 3 years related experience in IVD, medical, pharmaceutical, or other related industry in Quality department

**Technical Competencies**:

- Proficient in Advanced SPC, Quality Analysis Tools (Taguchi, Fishbone) & DOE.
- FDA Process Validation Techniques preferred

Personal Strengths
- Software product development experience within the IVD environment a plus

**Skills**:

- Good interpersonal skills, professionalism.
- Ability to work with cross -functional teams
- Time management skills and organization skills; analytical skills; Problem-solving
- Group work orientation.
- Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
- Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public

**Languages**:
Fluent spoken and written English.

Mobility

**Travel availability**:
On demand

**Benefits**:
WE OFFER YOU

As per local and Company requirements