375192BR
Sep 25, 2023
Italy
Job Description
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.
• Facilitates and participates in meetings, aligning internal review team and area subject matter experts on an agreed to investigational path forward.
• 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.
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.
• Facilitates and participates in meetings, aligning internal review team and area subject matter experts on an agreed to investigational path forward.
• 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.
Diversity & Inclusion / EEO
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Minimum 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.
Why Advanced Accelerator Applications?
Thousands of people die of cancer around the world every day. At Advanced Accelerator Applications, a Novartis company, our mission is to transform lives through radioligand therapy in nuclear medicine to fight several leading types of cancer. How will we continue to be on the cutting edge of medicine? We believe new groundbreaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working. We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying! Imagine what you could do here at Novartis!
Imagine what you could do at Novartis!
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
• 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.
Why Advanced Accelerator Applications?
Thousands of people die of cancer around the world every day. At Advanced Accelerator Applications, a Novartis company, our mission is to transform lives through radioligand therapy in nuclear medicine to fight several leading types of cancer. How will we continue to be on the cutting edge of medicine? We believe new groundbreaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working. We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying! Imagine what you could do here at Novartis!
Imagine what you could do at Novartis!
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
ONCOLOGY
ADVANCED ACCELERATOR APPLICATIONS
Italy
Colleretto Giacosa
AAA Italy Srl.
Quality
Full Time
Regular
Yes
