Quality Control Analyst

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.
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).


Job Description

769 million. That’s how many lives are touched by Novartis products globally.

The Quality Control Analyst will be responsible for Quality Control Chemical and Microbiological testing of Product and Raw Materials/packaging components as well operation/maintenance of analytical instrumentation in accordance with cGMP/FDA regulations, AAA standard operating procedures and Policies. Due to the nature of the process (radioactive) this role requires moderate proficiency, of the basic quality control techniques, analytical instrumentation, sterility principles and understanding of radiation safety standards.

General responsibilities will include but are not limited to the following:
• Supports all technical aspects related to quality control testing readiness including QC reagents and materials management, equipment preparation and daily cleaning and maintenance activities, sample management and QC testing, in full compliance with GMP regulation, AAA procedures and Product specifications
• Responsible for the oversight on Manufacturing for QC sampling activities
• Product testing and Environmental Monitoring QC testing and reporting of the results. Escalate in case of non-conformances and deviations, and manage these quality incidents as per AAA procedures
• Assist on deviation investigations, OOS/OOT investigations, CAPAs follow up and implementation and Change Controls
• Participation in assigned qualification/validation activities, as necessary; Responsible for successful on time completion of required training curriculum comprising of the necessary Standard Operating Procedures (SOPs) and Aseptic Techniques, Gowning Qualifications, Testing and specifications and other relevant training including HSE for the specific role
• Prepares applicable documents, forms and records such as analytical batch records and follows Good Documentation Practices and Support Audits and Inspections as required

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EEO Statement
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 other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

Minimum requirements

Education:
• A Bachelor’s degree in relevant Scientific discipline (e.g. Chemistry, Microbiology) is required

Experience & Requirements:
• A minimum of 2 years of experience in cGMP or aseptic environment is required
• Knowledge of cGMP regulations and FDA guidance applicable to Quality Control for product and Environmental Monitoring testing, Aseptic techniques required
• Basic knowledge and understanding of aseptic principles and techniques required
• Practical experience with physio-chemical techniques, and analytical instrumentation such as HPLC, GC, iTLC is highly preferred
• Basic knowledge of method/equipment validation principle and methodologies are required
• Ability to interpret analytical data and convert into technical documentation

You’ll receive:
Competitive salary, annual bonus, long term incentive (LTI) for select levels, health insurance, paid vacation/holidays, potential flexible working arrangements and employee recognition scheme.

At Advanced Accelerator Applications, we believe the answers are found when highly agile and collaborative people like you are brought together in an inspiring environment. Where you are given opportunities to explore transformative innovation. Where you are empowered to push boundaries/build innovation/challenge assumptions by taking smart risks, and where you’re surrounded by people who share your determination to seek the world’s toughest medical challenges.

Imagine what you could do at AAA! Start your career conversation today.

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