Principal Specialist, QC Lab General, Fremont CA

Principal Specialist, QC Lab General, Fremont CA Description

Employee assigned to QC functional or technical area in either HPLC/CE, Potency testing (Bioassay and Binding assays), Residual Impurities, Physicochemical/Drug Product, Raw Materials/Cleaning validation/verification. Performs duties under limited supervision and according to standard operating and QC procedures. Scientific and Quality lead for implementing novel methodologies and technologies within the site and global network. Group representative on new or complex equipment qualifications with impacts to global QC systems (e.g. Empower, LIMS, etc.).

Team lead responsible for the quality risk assessment, onboarding, qualification and implementation of non-routine, new equipment validation. Serves as a QC subject matter expert (SME) for critical processes with interdisciplinary impact on the site wide and global level. Change agent accountable for identification of novel processes or approaches that can improve QC methods or compliance. Responsible for concept design, strategy, and implementation of novel processes and technologies.

Cross functional team lead that independently handles complex deviations, OOS, investigations, CAPAs and change controls that impact multiple departments including (but not limited to) manufacturing, E&T and supply chain. Independently leads global team initiatives and external facing client teams. Author of regulatory documents (IND/IMPD/BLA), briefing book updates and regulatory response questions. Establishes timelines, sets goals, develops and implements strategy for cross site and global QC initiatives.

Improves cross training, coaches and mentors others. Serves as back up to Sr. Manager or Assoc. Dir./Sr. Assoc. Dir. As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success.

We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.

• Scientific and Quality lead for implementing new or novel methodologies and technologies within the site and global network. Group representative on new or complex equipment qualifications with impacts to global QC systems (e.g. Empower, LIMS, etc.). Team lead responsible for the quality risk assessment, onboarding, qualification and implementation of non-routine, new equipment validation. Change agent accountable for identification of novel processes or approaches that can improve QC methods or compliance.
  
  Responsible for compliance concept design, strategy, and implementation of novel processes and technologies.
• Cross functional team lead that independently handles complex, multi-faceted deviations, investigations, OOS, CAPAs and change controls that impact multiple departments including (but not limited to) manufacturing, E&T and supply chain. Serves as a QC subject matter expert (SME) for critical processes with interdisciplinary impact on the site wide and global level. Leads global team initiatives and external facing client teams.
• Documents work according to cGMP and cGDP.
• Adheres to established regulations and follows cGMP established by site.
• Reports abnormalities and deviations in a timely and accurate manner.
• Adheres to safety standards and identifies unsafe situations / habits and escalates appropriately.
• Author of regulatory documents (IND/IMPD/BLA), briefing book updates and regulatory response questions.
• Maintains own training within compliance and trains other technicians and associates on operations upon completion of trainer qualification. Conducts group trainings on complex topics and scientific principles as needed. Establishes training curricula and train others as a SME. Improves cross training, coaches and mentors others. Establishes timelines, sets goals, develops and implements strategy for cross site and global QC initiatives. Serves as back up to Sr Manager or AD/Sr.
  
  AD.
• Leads OOX and OOE investigations. Identifies protocol discrepancies and ensures they are properly defined, assessed and appropriate root causes are put in place. Influences and leads inter-site/business unit meetings with cross functional leaders to resolve issues and produce solutions. Quality and Technical leader for IND/IMPD and BLA/MAA sections related to analytical methods, validation, reference standards, justification of specifications, specifications, etc. Manages deviation investigations as applicable and provides product quality impact assessment.
  
  Leads complex deviation investigations as applicable and provides product…