Senior QC Lab Specialist – Method Transfer & Investigations

Boehringer Ingelheim GmbH; Fremont (CA); On-site; USD 75,000 - 122,000; Full time

Job summary

Boehringer Ingelheim GmbH in Fremont, CA seeks a Sr Specialist, QC Lab General to lead non-routine method transfers and validations in a GMP environment. The role covers technical assessments, QA ownership for new methods, and group representation on equipment qualifications for new tech.

Strong collaboration with cross-functional teams is essential. The position requires senior analytical testing experience, expertise in data review, and the ability to interact with auditors while maintaining

Qualifications

• Bachelor or higher degree in a science/engineering field with GMP analytical testing experience.
• Experience with technical data review, analysis and interpretation of scientific data.
• Proven ability to author SOPs, methods, and work instructions.
• Experience presenting complex technical problems to scientific experts.

Responsibilities

• Lead non-routine method transfers, validations, qualifications and verifications.
• Act as SME for QC data records, deviations, investigations and CAPAs.
• Interact with auditors/regulators and support inspection readiness.
• Manage cross-functional projects and provide training on complex topics.

Skills

GMP knowledge

Data integrity

Investigations & CAPA

Cross-functional collaboration

Education

Bachelor's degree in science or engineering

Master's degree in science or engineering

PhD in science or engineering (preferred)

Tools

TrackWise

Job description

Boehringer Ingelheim GmbH in Fremont, CA seeks a Sr Specialist, QC Lab General to lead non-routine method transfers and validations in a GMP environment. The role covers technical assessments, QA ownership for new methods, and group representation on equipment qualifications for new tech.

Strong collaboration with cross-functional teams is essential. The position requires senior analytical testing experience, expertise in data review, and the ability to interact with auditors while maintaining