US_Specialist, Quality Assurance

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.

This position offers a base salary typically between ($60,000) and ($97,000).  There is opportunity to consider higher compensation above this range based on business need, candidate experience and or skills.  The position may be eligible for a role specific variable or performance based bonus and or other compensation elements. 

• 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 revisions) in alignment with Boehringer Ingelheim governance.
• Perform approvals, as assigned, of master batch records, executed batch records, change control records, investigations, discrepancy risk assessments, complaint investigations, annual product reviews, supplier qualification records, and extension requests.
• Maintain shopfloor presence during GMP operations to provide in‑person oversight and auditing, ensuring adherence to SOPs, data integrity expectations, cleanroom behaviors, and identification of operational risks.
• Perform sampling and inspection activities—such as visual inspection checks—in accordance with applicable area SOPs.
• Exercise authority to suspend GxP operations when warranted, providing guidance on required remediation actions and escalating critical issues as needed.
• Engage professionally with manufacturing staff during area tours, clearly communicating observations and escalating trends to management when necessary.
• Perform additional quality‑related duties as assigned, including preparing documentation for regulatory submissions, contributing to site readiness for audits and inspections, and supporting compliance teams during such audits.
• Represent BI Fremont during audits and inspections, supporting and defending site practices, positions, and decisions when challenged.