Qc Investigator

5 mesi fa


Colleretto Giacosa, Italia Novartis A tempo pieno

387240BR

**QC Investigator**:
Italy

**AAA Statement**

**Advanced Accelerator Applications, a Novartis company, is an innovative medicines company focused on the development of products for targeted radioligand therapy and precision radioligand imaging. We are committed to transforming patients’ lives by leading innovation in nuclear medicine.**

**Advanced Accelerator Applications offers professionals the opportunity to face new challenges and pursue a career in a fast growing, technology driven healthcare company. We are passionate about improving patient health by leading innovation in nuclear medicine. We are looking for people who share our commitment to help us achieve this goal. Advanced Accelerator Applications is an Equal Opportunity Employer (EOE).**

**About the role**

The QC Investigator is responsible for the investigation and completion of laboratory investigations and non-conformances aimed at identification of root cause, assessing potential impact and implementation of corrective and preventive actions.

**Your key responsibilities**:
Your responsibilities include, but are not limited to:

- Assists to determine the validity of data, and determination of out of specification results.
- Authors minor and major laboratory investigation reports and non-conformances related to QC testing.
- Works in the QC laboratories in order to gather data, observe testing for investigations, and interview employees.
- Performs appropriate root-cause analysis for complex events utilizing investigation tools (e.g., 5 Whys, Fishbone Diagrams).
- Assigns and implements proper corrective action and preventive action (CAPA) to resolve and prevent recurrence of events.
- Conflict resolution, complex problem solving in a cross functional setting, and ability to meet timelines for closure of exception events.
- Remains current in regulatory expectations and industry practices regarding investigations, change controls and CAPAs.
- Management of multiple projects and timelines concurrently
- Adheres to standard timeline and escalate actions appropriately for resolution in a timely manner.
- Initiates, owns, and drives change controls related to QC operations.
- Technical writing to support QC operations including but not limited to, Standard Operating Procedures (SOP), Test methods, change controls, training documentations, protocols, and white papers.

**Commitment to Diversity & Inclusion**:

- We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._

**Role Requirements**

**What you’ll bring to the role**:

- Scientific Degree and/or technical background in a similar role.
- At least 3 years’ experience in a similar role.
- Strong working knowledge of biopharmaceutical QC testing operations, the ability to manage multiple ongoing project concurrently, have strong meeting facilitation and conflict resolution skills, a strong technical writing capability, be action oriented and compliant minded while performing investigations.
- Proficient in Italian. Good knowledge of English.
- Team player mindset and good communication skills.

Work location: Colleretto Giacosa.

**Division**

Oncology

**Business Unit**

ADVANCED ACCELERATOR APPLICATIONS

**Work Location**

Colleretto Giacosa

**Company/Legal Entity**

AAA Italy Srl.

**Functional Area**

Quality

**Job Type**

Full Time

**Employment Type**

Regular

**Shift Work**

No

**Early Talent**

Yes