QC Supervisor - Microbiology (Th-Sun) Days

**383292BR** **Job ID:** 383292BR **About the role:** Location: Indianapolis, IN About the role: At Advanced Accelerator Applications, a Novartis company, we are committed to leading innovation in nuclear medicine and delivering the next generation of targeted radioligand therapy to cancer patients. We are looking for inspired professionals to help us reach our ambitious goals. Key Responsibilities: ** Supervision of all QC Microbiology laboratory testing** • Sustain environmental monitoring programs • Management and optimization of the Aseptic gowning training and qualification program, and management of QC Microbiology training program. • Works with QC raw materials team to establish specifications and testing process of raw materials. • Assembles reports on findings from environmental monitoring of cGMP facility. Frequently update management on environmental trends. Implement corrective action plans when necessary. • Completes routine record review of test data and related documents for in-process testing, drug substance and drug product release. Generation of CoAs for product release. • Develops, revises and reviews SOPs, qualification/validation protocols and reports. Conducts investigations regarding out of specifications (OOS) results and address and manage non-conformances related to micro procedures. • Provides updates at daily and weekly meetings. • Monitors the GMP systems currently in place to ensure compliance with documented policies. Reviews proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriate. • Gathers metric information for use in continuous improvement of areas of responsibility. • Support regulatory inspections and audits. Additional Notes: • This role is for our day shift and the workweek will be Thursday - Sunday from 8AM - 6:30PM. \n\n\n\n **Position Title:** QC Supervisor - Microbiology (Th-Sun) Days **Role Requirements:** Essential Requirements: • Bachelor’s degree in relevant Microbiology discipline or equivalent practical experience in Supervision of Microbiology related activities including but not limited to EM monitoring and product testing for microbiology. • Minimum of 3 years’ experience in Quality Control in cGMP or aseptic environment required. • 1 year experience supervising/managing/leading microbiology and environmental monitoring labs within the biotechnology or pharmaceutical industry. • Demonstrated leadership and management skills, including establishing direction and goals, and guiding execution while fostering a team-based environment. • Ability to gown for entry into Aseptic core and supporting areas, and lift up to 25 lbs. • Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211), Quality Control, cGMPs, microbiological method development and validation. • Identifying, writing, evaluating and closing OOS investigations. Strong knowledge of aseptic manufacturing and EM processes. • Experience in the application of microbiological techniques including rapid release methods, and qualifying EM processes. • Good Knowledge of cGMP regulations and FDA guidance Why Novartis: Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture The pay range for this position at commencement of employment is expected to be between $88,000.00 and $132,000.00 per year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards Accessibility and Reasonable Accommodations: The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to tas.nacomms@novartis.com call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message. 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: Novartis Talent Pool. **Job Type:** Full Time **Country:** USA **Work Location:** Indianapolis, IN **Functional Area:** Quality **Division:** Operations **Business Unit:** QUALITY **Employment Type:** Regular **Company/Legal Entity:** AAA USA Inc. **Commitment to Diversity & Inclusion::** _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._ **Shift Work:** No **Early Talent:** Yes