Specialist, Quality Assurance, Onsite, Fremont CA

The base salary range for this position is $74,800 to $112,200. The position may be eligible for a role-specific discretionary bonus, relocation assistance, 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, qualifications, and other factors permitted by law.

Benefits include medical, dental, and vision coverage, retirement savings opportunities, paid time off, paid holidays, disability and life insurance benefits, and other company-sponsored benefits. For additional information regarding our benefits and Total Rewards offerings, please  .

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.

The Specialist, Quality Assurance executes assigned quality activities to ensure full compliance with product requirements, cGMP regulations, applicable regulatory standards, internal quality policies, and established customer commitments. In this role, the Specialist applies sound judgment and attention to detail to maintain product integrity and ensure that operations remain aligned with the organization’s quality systems and expectations.

The Specialist also leads, supports, and contributes to minor, well-defined cross-functional continuous improvement initiatives. These efforts help strengthen product quality, enhance operational consistency, and maintain a high level of regulatory readiness. Through effective collaboration with peers and partner functions, the Specialist plays an active role in improving processes, resolving simple issues, and supporting the delivery of high-quality products.

• Execute assigned quality activities to ensure compliance with product requirements, cGMP regulations, regulatory standards, internal quality policies, and customer commitments.
• Apply sound judgment and attention to detail to maintain product integrity and ensure alignment with the organization’s quality systems.
• Lead, support, and contribute to minor, well-defined cross-functional continuous improvement initiatives that strengthen product quality and regulatory readiness.
• Collaborate effectively with peers and partner functions to improve processes, resolve simple issues, and support high-quality product delivery.
• Support subject matter experts (SMEs) and management system owners (MSOs) in completing straightforward tasks, such as SOP updates required by CAPA activities.
• Perform data collection, assessment, evaluation, and periodic trending and reporting as defined in area SOPs.
• Contribute to preparation of annual and periodic quality reviews, failure trending, and KPI data as assigned.
• Support implementation of the Batch Disposition quality system by contributing to documentation readiness, data collection, and discrepancy resolution to enable timely disposition.
• Allow, endorse, or approve predefined activities (e.g., change records), assessments (e.g., trending reports), documents (e.g., protocols), and minor procedural updates (e.g., SOP…