SR Specialist OR 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. 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 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.

Sr Specialist: Requirements

• Bachelors Degree in a science or engineering related field from an accredited institution, with six (6) years of experience in analytical testing in a GMP regulated industry or equivalent; Or
• Masters Degree in a science or engineering related field from an accredited institution, with four (4) years of experience in analytical testing in a GMP regulated industry or equivalent: Or
• PhD in a science or engineering related field from an accredited institution, with two (2) years of experience in analytical testing in a GMP regulated industry or equivalent. PhD preferred.
• 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 providing oral and poster presentations on complex technical problems to other scientific experts.
• 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.
• Ability to interact with auditors and regulators, clearly understand subject matter and concisely communicate within areas of subject matter expertise.
• Proven capability to independently solve complex technical problems.
• Demonstrated ability to lead cross functional projects of moderate complexity.
• Proven track record to mentor, train and lead others within discipline.

Desired Skills, Experience and Abilities

. This role is responsible for ensuring the quality, compliance, and data integrity of QC records while maintaining inspection readiness and supporting continuous improvement initiatives across the organization.

• Strong knowledge of GMP regulations, data integrity principles, investigations, CAPA management, Change Controls, and inspection readiness.
• Demonstrated experience leading complex investigations and cross-functional projects.
• Excellent technical writing, communication, and organizational skills.
• Ability to influence stakeholders and drive projects to completion in a fast-paced environment.
• Experience with quality systems such as TrackWise or similar electronic quality management systems is preferred.
• Knowledge of microbiology, aseptic manufacturing, environmental monitoring, and contamination control strategies is highly desirable.

• Ensure compliance and quality oversight of QC records, data integrity controls, and documentation practices.
• Support audit and inspection readiness activities, including preparation, management of responses, and follow-up actions.
• Author and review trend reports, compliance metrics, and quality assessments.

This position offers a base salary typically between (75,000) and (122,000).

The position may be eligible for a role specific discretionary bonus, relocation, and/or other compensation elements. We continuously review market data and may adjust salary ranges as needed in the future. Actual compensation will be based on job-related factors such as skills, experience, and qualifications, and other factors permitted by law. For an overview of our benefits please click here.