Onsite QA Specialist – Fremont: Growth & Impact

Boehringer Ingelheim GmbH; Fremont (CA); On-site; USD 75,000 - 112,000; Full time

Job summary

Boehringer Ingelheim is hiring a Specialist, Quality Assurance for onsite work in Fremont, CA. The role ensures compliance with cGMP, regulatory standards and internal quality policies, while maintaining product integrity and readiness for audits.

You will lead small cross-functional improvement initiatives and collaborate with Manufacturing, QA, QC and MSAT to deliver high‑quality products. The position emphasizes demonstrated QA experience in life sciences, attention to detail, and ability to

Qualifications

• Bachelor’s degree in a scientific discipline with a minimum of 3 years 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.

Responsibilities

• Execute assigned quality activities to ensure compliance with product requirements, cGMP regulations, internal quality policies, and customer commitments.
• Maintain product integrity and ensure alignment with the organization’s quality systems.
• Lead minor cross-functional continuous improvement initiatives to strengthen product quality and regulatory readiness.
• Collaborate with peers and partner functions to improve processes and support high‑quality product delivery.
• Support SMEs and 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 annual and periodic quality reviews, failure trending, and KPI data as assigned.
• Support Batch Disposition quality system activities including documentation readiness and discrepancy resolution.

Job description

Boehringer Ingelheim is hiring a Specialist, Quality Assurance for onsite work in Fremont, CA. The role ensures compliance with cGMP, regulatory standards and internal quality policies, while maintaining product integrity and readiness for audits.

You will lead small cross-functional improvement initiatives and collaborate with Manufacturing, QA, QC and MSAT to deliver high‑quality products. The position emphasizes demonstrated QA experience in life sciences, attention to detail, and ability to