Supply Chain Quality Systems and Documentation Specialist

Supply Chain Quality Systems and Documentation Specialist
Advanced Accelerator Applications, a Novartis company, is an innovative radiopharmaceutical company developing, producing and commercializing molecular nuclear medicine theragnostics. AAA 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).
• Support cGMP documentation of product complaints/ product failure reports for all products
• Manage investigations for QC failures, adverse reactions, and other quality issues
• Interface with QA department to ensure compliance
• Maintain records of radiopharmacy visits and training
• Support adherence to Quality Agreements by radiopharmacy network.
• Update SharePoint daily and communicate daily QC failures to manufacturer
• Support adherence to local SOPs
• Provide initiative and support in opening of department deviations and other quality documentation.
• Support in development of SOPs, investigation forms, agreements
• Maintain team’s training documents and facility training initiatives.
• Provide strong support to meetings involving corporate QA
• Document meetings for the Supply Chain team to assist the department in completing requested actions.
• Provide light project management and tracking of ongoing investigations.
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
• Bachelor’s degree in a related field, supply chain management, quality, engineering.
• 2+ year’s experience in a similar role in cGMP within the pharmaceutical industry preferred.
• Experienced in quality management systems.
• Proficient in Microsoft Office.
• Knowledge and experience working in ERP systems (preferably Microsoft Dynamics AX)
• Highly organized and detail-oriented with strong focus on accuracy
• Ability to work well under pressure and have excellent interpersonal and communication skills
• Knowledge of nuclear medicine industry is a plus
• Ability to work in a small entrepreneurial company
• Excellent interpersonal and communication skills
• Minimum Bachelor’s Degree with a Science background
• Demonstrates strong personal ethics and responsibility to purpose
• Ability to work independently / self-starter
East Hanover, NJ
Full Time