QC Lab Specialist: Process Improvement & Compliance

Boehringer Ingelheim GmbH; Fremont (CA); On-site; USD 88,000 - 132,000; Full time

Benefits offered by this job

Medical, dental, and vision coverage

Retirement savings opportunities

Paid time off

Paid holidays

Disability and life insurance

Other company-sponsored benefits

Job summary

Boehringer Ingelheim is seeking a Specialist, QC Lab General, onsite in Fremont, CA to provide technical oversight of analytical testing across multiple product lines. You will be SME for 3–5 analytical methodologies and lead routine method transfers, validations, and investigations in a GMP environment.

The role emphasizes quality review, compliance deliverables, and collaboration with cross-functional teams.

Qualifications

• Four (4) years of work experience in analytical testing in a GMP regulated industry or equivalent.
• MS/MA with two (2) years of work experience in analytical testing in a GMP regulated industry or equivalent.
• Experience with technical review, analysis and interpretation of scientific data.

Responsibilities

• Provides technical oversight and reviews QC analytical testing in a multi-product facility.
• Lead routine method transfers, validations, and qualifications with oversight.
• Document work according to cGMP/cGDP and quality systems.
• Coordinate audits, deviations and CAPAs and drive continual improvement.

Education

BS/BA in science or engineering related field

MS/MA in science or engineering related field

Job description

Boehringer Ingelheim is seeking a Specialist, QC Lab General, onsite in Fremont, CA to provide technical oversight of analytical testing across multiple product lines. You will be SME for 3–5 analytical methodologies and lead routine method transfers, validations, and investigations in a GMP environment.

The role emphasizes quality review, compliance deliverables, and collaboration with cross-functional teams.