Quality External Manufacturing Americas Intern- Spring 2020
- Opportunity Profile:
Position: Intern Quality External Manufacturing Americas
Department: Pharmaceutical External Manufacturing Americas - Quality
Location: New Brunswick, NJ
Job Function: Assist with quality and compliance oversight management to the Quality Operations group in External Manufacturing (ExM) Quality by assisting with processes related to major / critical investigations, managing relationships with Health Authorities, and managing Quality Agreements, management of documentation related to product disposition, management of records within the Trackwise system for change controls, deviations and CAPAs.
Assist in the organization and support the BMS Market Action Fact Finding (FF) and Product Review Committee (PRC) processes for major / critical investigations involving Third Party products.Prepare Product Hold Notices.
Prepare slide presentations for Product Action Committees for recalls associated with Contract Manufacturing Organizations (CMOs) managed by ExM.
Author No Field Alert justification memos, where required.
Draft and track the progress of Quality Agreements with the CMOs and Alliance Partners and Marketing Authorisation Holders, including those associated with multiple CMOs/BMS parties and External Manufacturing Quality operations personnel.
Develop tracking tools and vision boards for quality compliance.
Assist in the hosting health authority inspections of External Manufacturing America.
Implementation of new Quality Metrics guidance within the External Manufacturing group by establishing systems for gathering data from Contract Manufacturers (CMOs).
Provides Quality Assurance support for Contract Manufacturing Operations (CMOs) within a cross functional team. Primary responsibility is to support Quality Operations Managers/ Associate Directors with management of CMOs, documentation related to product disposition, and projects to ensure CMOs compliance with applicable FDA and international regulatory requirements.
Support Quality systems processes (e.g. management of records within the TrackWise® system for change controls, complaints, deviations and CAPAs). Support Quality Metrics within the External Manufacturing group by gathering data from Contract Manufacturers (CMOs).
Provide Quality Assurance support for Contract Manufacturing Operations (CMOs) within a cross functional team for change controls, deviations, CAPAs and complaints tracking.
Support Quality Operations Managers/ Associate Directors with management of CMOs, documentation related to product disposition, and packaging transfer products to ensure CMOs compliance with applicable FDA and international regulatory requirements.
- In depth knowledge of cGMP regulations pertinent to the USA, EU and other international markets
- Ability to assess the right balance between business targets and scientific and quality decisions
- Strong negotiation, communication and presentation skills across all levels both internal and external to BMS. Exhibit BMS BioPharma Behaviors
- Strong analytical and problem solving skills
- Must have strong analytical, interpersonal, communication, organization, and project management skills.
- Must demonstrate the ability to present ideas, issues, and observations into a clear and useful format, and balance several projects in a fast-paced team environment.
- Must have the ability to collect, analyze, and integrate information by leveraging appropriate PC/systems technology including Word, Excel, Access and PowerPoint.
- Must be able to adapt to rapidly changing environment and circumstances demonstrating flexibility, tolerance and sense of urgency.
Required Qualification(s) and Desired Experience: B.S. in Natural Sciences, Chemistry, Microbiology, Biology, or PharmacyBMS BioPharma Behaviors: The qualified candidate demonstrates characteristics of our BMS BioPharma Behaviors. For more details refer to InSite BMS Website/ People and Performance/BMS BioPharma Behaviors.