GMP Quality Assurance Specialist

BoehringerPRD; Fremont (CA); On-site; USD 75,000 - 112,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Retirement plan

Paid time off

Paid holidays

Job summary

Boehringer Ingelheim Fremont seeks a Specialist, Quality Assurance to execute quality activities and ensure cGMP compliance, product integrity, and readiness for inspections. You will collaborate across QA, QC, Operations and MSAT; lead small cross‑functional improvement efforts; perform data collection, trending, CAPA support and regulatory submissions.

Qualifications: bachelor’s degree in a scientific field with 3+ years QA experience, or HS diploma with 7 years QA experience.

Qualifications

• Bachelor’s degree in a scientific field with at least 3 years QA experience.
• Alternative: High School Diploma with 7 years QA experience in life sciences.

Responsibilities

• Execute quality activities to ensure product requirements and cGMP compliance.
• Maintain data integrity and support regulatory readiness.
• Lead minor cross-functional continuous improvement initiatives.
• Support CAPA, trend analysis, and quality reviews.
• Represent BI Fremont during audits and inspections.

Skills

Quality Assurance

cGMP

Data integrity

Education

Bachelor's degree in a scientific field

High School Diploma + 7 years QA experience

Job description

Boehringer Ingelheim Fremont seeks a Specialist, Quality Assurance to execute quality activities and ensure cGMP compliance, product integrity, and readiness for inspections. You will collaborate across QA, QC, Operations and MSAT; lead small cross‑functional improvement efforts; perform data collection, trending, CAPA support and regulatory submissions.

Qualifications: bachelor’s degree in a scientific field with 3+ years QA experience, or HS diploma with 7 years QA experience.