Specialist, Quality Assurance, Fremont CA ONSITE

Description

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.

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.

Duties & Responsibilities

• 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.

Requirements

• Requires a bachelor’s degree, preferably in a scientific discipline, with a minimum of 3 years of experience in Quality-related aspects of the life sciences or a closely related industry.
• In lieu of a bachelor’s degree, a High School Diploma plus 7 years of experience in Quality-related roles within the life sciences or a closely related industry is acceptable.

Communications

• Written: Authors clear impact assessments and investigation narratives supported by traceable evidence.
• Verbal: Provides audience‑aware status updates; frames risk, impact, and required decisions; confirms actions and ownership.
• Digital: Uses collaboration tools and quality systems reliably; prepares and presents Pareto and trend views to support decision‑making.

Leadership & Stakeholder Management

• Coordinates day‑to‑day alignment across QA, QC, Operations, and MSAT; ensures handoffs are fully closed.
• Manages personal workload relative to critical path priorities and flags capacity risks early.
• Models right‑first‑time behaviors and contributes to team learning and continuous improvement.

Technical & Operational Excellence

• Interprets cGMP requirements in context; authors sound, compliant records; ensures inspection readiness.
• Connects process controls to quality risk and supports validation and qualification reviews.
• Leads root cause analyses for moderate issues; drafts CAPAs with defined effectiveness checks; evaluates reports and trends and ties insights to actions and APR/PQR inputs.

Preferred Qualifications

• Experience supporting Quality Agreements (QAAs).

• Experience as a local management system owner or deputy, including KPI stewardship.

• Hands‑on experience with packaging/label control checks, drug substance or laboratory areas, and sampling/inspection activities in the assigned area.

• Participation in internal audits or inspection readiness activities.

Eligibility Requirements:

• Must be legally authorized to work in the United States without restriction.
• Must be willing to take a drug test and post-offer physical (if required).
• Must be 18 years of age or older.

Desired Skills, Experience and Abilities

• Knowledge of pharmaceutical manufacturing processes for drug substance and drug product
• Knowledge of analytical testing and quality control concepts
• Knowledge of applicable regulations and guidance including:
  • 21 CFR Parts 210 and 211
  • ICH guidelines
• Ability to review batch production records, laboratory results, deviations, and supporting documentation for completeness and compliance
• Familiarity with batch disposition activities including:
  • Batch record review
  • Material status verification
  • Deviation assessment support
  • Release documentation preparation
• Understanding of data integrity principles (ALCOA+ concepts)
• Experience with Trackwise for:
  • Change control
  • CAPA (Corrective and Preventive Actions)
  • Deviations
• Experience using SAP and LIMS is preferred
• Clear written and verbal communication skills
• Ability to work cross-functionally with:
  • Manufacturing
  • Quality Assurance
  • Quality Control
  • Supply Chain