QC Microbiology Expert

Novartis Group
NJ, New Jersey, US
Jul 15, 2021
Jul 24, 2021
Employment Type
Full time
Salary Type
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. And, while we're proud of that fact, in this world of digital and technological transformation, we must ask ourselves this: how can we continue to improve and extend even more people's lives?
The Microbiology Expert, Quality Control is responsible for implementing, maintaining QC microbiology of Quality Control testing for Product and Environment in compliance with GMP/FDA regulations, AAA standard operating procedures and Product specifications.

General responsibilities will include but are not limited to the following:
• Supports QC Manager in all planning, coordination, and execution of QC microbiology related activities.
• Acts as QC Single Point of Contact for all microbiology related activities, including projects for the Millburn, NJ facility. Primary contact for technical troubleshooting and compliance for microbiology related matters.
• Ensures that all microbiological aspects of manufacturing and testing of products comply with GMP/FDA regulations and AAA guidelines, and are conducted per local SOPs
• Along with Quality Assurance, ensures training compliance in manufacturing and QC area related to microbiology, aseptic behavior, gowning, and sterility assurance principles.
• As Subject Matter Expert, manage critical microbiological issues, e.g. EM excursion in class A, sterility failures, media fill failures
• Responsible for all technical aspects and procedures related to microbiology quality control testing readiness including QC reagents and materials management, cleaning and maintenance activities, sample management and QC testing.
• Responsible for the oversight on Manufacturing for QC sampling activities for sterility testing and microbiological testing.
• Review Product testing and Environmental Monitoring for microbiology QC testing and reporting of the results. Escalate in case of non-conformances and deviations and manage these quality incidents as per AAA procedures.
• Performs deviation investigations, OOS/OOT investigations, CAPAs and Change Controls. Liaise with QA to ensure compliance activities are performed timely.
• Prepare EM reports, assess trends and make recommendation.
• Responsible for establishing regular meetings and proper KPIs, in the areas of EM and aseptic expert team. SPOC for Millburn AAA aseptic network team.
• Responsible for continuous improvements in microbiology at site, and in aseptic practices; develop site personnel in microbiology and aseptic practices.


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.

Bachelors degree; PhD or MSc in Microbiology is preferred
 5+ years industry microbiology quality control experience, 3+ years of sterility assurance or sterile manufacturing experience
 Related experience should be in GMP-regulated industries in Quality Control.
 Must have a working knowledge of FDA and ex-USA regulatory requirements as well as industry quality management tools, standard, and quality systems.
 Must understand pharmaceutical industry trends and practices. Broad cGMP experience is required with knowledge and understanding of manufacturing, quality control, and validation requirements and activities.
 Good leadership skills (communication, team-working with other departments, drive to enable problem solving)
 Open and clear collaboration and communication to make sure the daily production operation runs smoothly
 Shows the appropriate sense of urgency around given tasks
 Excellent technical writing skills

Why Advanced Accelerator Applications (AAA)?
Thousands of people die of cancer around the world every day. At Advanced Accelerator Applications (AAA), 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!

Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse team's representative of the patients and communities we serve.

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network

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