QC Associate II: GMP Lab Analytics & Compliance

Boehringer Ingelheim; Fremont (CA); On-site; USD 85,000 - 110,000; Full time

Job summary

Boehringer Ingelheim in Fremont, CA, seeks a QC analyst to perform routine and non-routine testing in a multi-product facility. You will review results, investigate atypical findings, and contribute to cGMP compliance.

Key responsibilities include leading cross-functional teams on deviations, CAPAs, and change controls; supporting audits; and maintaining training and safety standards while collaborating with multiple departments to ensure timely, accurate analytics.

Qualifications

• Bachelor's degree in Biology or Life Sciences required.
• 3–5 years of GMP industry experience preferred.
• Strong interpersonal and communication skills.
• Ability to work independently and with cross-functional teams.

Responsibilities

• Provide expertise on routine and non routine testing in QC laboratories.
• Technical review, interpretation, trending, and investigation of atypical results.
• Assist with quality risk assessments, onboarding, qualification and equipment validation.
• Lead cross-functional project teams on deviations, investigations, CAPAs and change controls.
• Support during audits and inspections and maintain safety compliance.
• Review analytical results within timelines and ensure compliance with cGMP/cGDP.

Skills

GMP experience

Strong communication

Team collaboration

Attention to detail

Education

Bachelor's degree in Biology or Life Sciences

Job description

Boehringer Ingelheim in Fremont, CA, seeks a QC analyst to perform routine and non-routine testing in a multi-product facility. You will review results, investigate atypical findings, and contribute to cGMP compliance.

Key responsibilities include leading cross-functional teams on deviations, CAPAs, and change controls; supporting audits; and maintaining training and safety standards while collaborating with multiple departments to ensure timely, accurate analytics.