Quality Assurance Specialist - GMP Compliance & Audits

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

Benefits offered by this job

Discretionary bonus

Relocation assistance

Job summary

Boehringer Ingelheim Fremont is seeking a Specialist, Quality Assurance to execute quality activities and ensure compliance with product requirements and cGMP standards. This role supports regulatory readiness and continuous improvement initiatives across QA, QC, and Operations.

The position emphasizes collaboration with cross-functional teams, data collection and trend analysis, and contributing to regulatory submissions and audits to maintain high quality and readiness at the site.

Qualifications

• Requires a bachelor’s degree with a minimum of 3 years of experience in Quality-related aspects of life sciences.
• In lieu of a bachelor’s degree, a high school diploma plus 7 years of relevant quality experience is acceptable.

Responsibilities

• Execute quality activities to ensure compliance with product requirements and cGMP.
• Lead minor cross-functional continuous improvement initiatives to strengthen quality and readiness.
• Collaborate with manufacturing staff during audits and area tours.

Skills

Quality Assurance

cGMP knowledge

Regulatory compliance

Data trend analysis

CAPA processing

Education

Bachelor's degree

High School Diploma +7 years

Job description

Boehringer Ingelheim Fremont is seeking a Specialist, Quality Assurance to execute quality activities and ensure compliance with product requirements and cGMP standards. This role supports regulatory readiness and continuous improvement initiatives across QA, QC, and Operations.

The position emphasizes collaboration with cross-functional teams, data collection and trend analysis, and contributing to regulatory submissions and audits to maintain high quality and readiness at the site.