Principal/Senior/Specialist, QC Lab General, Fremont CA
Principal/Senior/Specialist, QC Lab General, Fremont CA
Full Job Description
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. Technical and Quality lead for non-routine, new method transfer / validations / qualifications, verifications and technical assessments. Responsible for quality and compliance activities including new test methods, specs, plans, reports, forms, SOPs, etc. with no previous experience within the department. Group representative on equipment qualifications for new and novel technology. Team lead responsible for the quality risk assessment, onboarding, qualification and implementation of non-routine, new equipment validation. Identifies and implements novel improvements and new ways of thinking toward lab processes and compliance activities. Cross functional project team lead responsible for complex QC related compliance deliverables throughout the entire Quality System (deviations, investigations, OOS and CAPAs and change controls) with impact across multiple functional areas in the QC department. Serves as a QC subject matter expert (SME) representing the department during audits for critical processes with impact across multiple functional areas in the QC department. Represents team on global team initiatives and external facing client teams. Project leader of non-routine, new initiatives with local cross functional impact. Establishes training curricula and train others as a SME. Establishes timelines, sets goals and implements strategy for site wide QC projects.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, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.Duties & Responsibilities
- Technical and Quality lead for non-routine, new method transfer/validations/qualifications, verifications and technical assessments. Group representative on equipment qualifications for new and novel technology. Team lead responsible for the quality risk assessment, onboarding, qualification and implementation of non-routine, new method equipment validation.
- Identifies and implements novel improvements and new ways of thinking toward lab processes and compliance activities. Responsible for quality and compliance activities including new test methods, specs, plans, reports, forms, SOPs, etc. with no previous experience within the department. Cross functional project team lead responsible for complex QC related compliance deliverables throughout the entire Quality System (deviations, investigations, OOS and CAPAs and change controls) with impact across multiple functional areas in the QC department. Serves as a QC subject matter expert (SME) representing the department during audits for critical processes with impact across multiple functional areas in the QC department.
- 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.
- Represents team on global team initiatives and external facing client teams. Project leader of non-routine, new initiatives with local cross functional impact. Establishes timelines, sets goals and implements strategy for site wide QC projects.
- 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. Implements new training procedures and drives continuous improvement. Improves cross training and coaches others.
- Leads OOX and OOE investigations.
- Identifies protocol discrepancies and ensures they are properly defined, assessed and appropriate root causes are put in place.
- Responsible for technical review, interpretation, trending, quality review and investigation of atypical results. Influences and leads inter-departmental meetings with cross functional managers to resolve issues and produce solutions.
- Manages deviation investigations as applicable and provides product quality impact assessment.
- Leads complex deviation investigations as applicable and provides product quality impact assessment.
- Responsible for training others.
Additional Information
Job Information
Job Category:
Manufacturing
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