GMP Quality Assurance Specialist – Compliance & Improvement

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

Job summary

Boehringer Ingelheim Pharmaceuticals, Inc. in Fremont, CA seeks a Specialist, Quality Assurance onsite to execute quality activities and ensure compliance with cGMP and regulatory standards.

The role emphasizes maintaining product integrity, contributing to continuous improvement, and supporting audits to keep operations audit-ready. The position requires a science degree with 3+ years in life sciences quality roles, and offers base salary within a defined range with potential bonuses based on

Qualifications

• Bachelor’s degree in a scientific discipline preferred with 3+ years in quality-related life sciences.
• Alternative: High School Diploma plus 7 years quality experience in life sciences.
• Experience interpreting cGMP requirements and quality systems.

Responsibilities

• Execute quality activities ensuring compliance with product requirements and cGMP regulations.
• Maintain product integrity and align operations with quality systems.
• Lead minor cross-functional continuous improvement initiatives.
• Collaborate with QA, QC, Operations, and MSAT for process improvements.
• Support CAPA activities and documentation for regulatory submissions.
• Contribute to data collection, trend reporting, and quality reviews.
• Assist in audits and inspections to ensure site readiness.

Skills

Quality assurance

cGMP

Regulatory readiness

Data integrity

Cross-functional collaboration

Audit readiness

Documentation

CAPA

Education

Bachelor’s degree in science (BS/BA)

High School Diploma + 7 years quality experience

Tools

SAP

LIMS

TrackWise

Job description

Boehringer Ingelheim Pharmaceuticals, Inc. in Fremont, CA seeks a Specialist, Quality Assurance onsite to execute quality activities and ensure compliance with cGMP and regulatory standards.

The role emphasizes maintaining product integrity, contributing to continuous improvement, and supporting audits to keep operations audit-ready. The position requires a science degree with 3+ years in life sciences quality roles, and offers base salary within a defined range with potential bonuses based on