The Specialist Quality Assurance - Quality Control, ensures Novartis Gene Therapies products are manufactured to relevant patient safety
and product quality standards in line with business requirements.
**Your key responsibilities**:
Your responsibilities include, but are not limited to:
- Provide QA oversite for the development, qualification, validation, and transfer of analytical methods
- Monitors routine method and equipment performance for trends and adherence to existing and new quality standards
- Interprets characterization, product release, and stability data
- Partecipates in establishment / revision of drug substance and drug product specification for IND, IMPD and BLA submission
- Supports invalid assay and aborted assay investigations
- QA representative for the investigation and resolution of out-of-specification (OOS) and out-of-trend (OOT) testing results
- Provides support to ensure successful accomplishment of business goals
**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._
**Minimum requirements**
**What you'll bring to the role**:
- Bachelor's Degree in a scientific discipline with 5 years working experience in the Biotech/Pharmaceutical industry dependent and 5 years working directly with or supporting laboratory functions.
- Strong knowledge of USP, ICH, and Ph Eur regulations as they relate to Quality Control
- Experience working with teams implementing lean processes into a GMP lab or manufacturing environment.
- Good critical thinking, deductive reasoning, and decision-making skills.
- Approximately 10% travel.
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!
**
**Division**
Oncology
**Business Unit**
ADVANCED ACCELERATOR APPLICATIONS
**Country**
Italy
**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