Fremont, CA SR Specialist OR Specialist, QC Lab General, Fremont CA Unit

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, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees. Specialist: Duties & Responsibilities Provides technical oversight, coordinates and reviews QC analytical testing of bulk drug substance and drug product in a multi-product facility. SME in 3-5 analytical methodologies within different scientific principles. Technical and Quality Lead for routine or platform method transfer/validations/qualifications, verifications and technical assessments. Identifies and implements new improvements to lab processes and compliance activities. Responsible for quality and compliance activities (new test methods, specs, plans, reports, forms, SOPs) that are new or non-routine. Executes with oversight new, multi-faceted QC related compliance deliverables within different areas of the Quality System (deviations, investigations, OOS and CAPAs and change controls). Serves as QC subject matter expert (SME) representing the department during audits for 3-5 core within group. 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. Establishes lab areas according to predefined standards (5s). Group representative on simple or routine equipment qualifications. Managing projects of core or platform within Quality. 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. Leads OOX and OOE investigations. Identifies protocol discrepancies and ensures they are properly defined, assessed and appropriate root causes are put in place. Manages deviation investigations as applicable and provides product quality impact assessment. Ensures deviations assigned are promptly closed. Responsible for training others. Responsible for technical review, interpretation, trending, quality review and investigation of atypical results. Influences and leads inter-departmental meetings with cross functional team members to resolve issues and produce solutions. Specialist: Requirements BS/BA from an accredited institution in a science or engineering related field, with four (4) years of work experience in analytical testing in a GMP regulated industry or equivalent; Or MS/MA from an accredited institution in a science or engineering related field, with two (2) years of work experience in Analytical testing in a GMP regulated industry or equivalent. Proven experience with technical review, analysis and interpretation of scientific data. Experience with computer-based systems and ideally experience with process control systems. Previous experience authoring SOPs, methods, and/or work instructions. Experience interacting with auditors and regulators, clearly understand subject matter and concisely communicate within areas of subject matter expertise. Experience troubleshooting technical problems and/or equipment. Subject matter expert in performing analytical methodologies within different scientific principles relevant to Biopharmaceutical manufacturing. Expert in analytical methods, execute critical decision making, work independently with very little supervision, champions problem resolution, knows when to escalate to upper management, and provides compliant and smart solutions for complex validation issues. Expert understanding of analytical methods and validation principles in pharmaceutical / biopharmaceutical / medical device industries. Ability to concentrate on detail oriented work in a complex technical setup with a Quality and Right the first time mindset. Track record of troubleshooting and applying the scientific method to solve technical problems. Skills in Quality Systems (CAPA, CC, Deviations, OOX, etc.). Ability to work as part of a high performing team and collaborate effectively with staff. Demonstrated ability to lead projects of low complexity. Sr Specialist: 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 f