Senior QC Lab Specialist: Method Transfers & Compliance

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

Job summary

Boehringer Ingelheim GmbH in Fremont, CA is seeking an SR Specialist OR Specialist for QC Lab General duties. The role provides technical and quality leadership for non-routine method transfers, validations, verifications and assessments within a multi-product QC environment.

The position leads quality risk assessments, onboarding, training, and implementation of new equipment validation. It requires strong GMP experience, cross-functional collaboration and ability to interact with audits and

Qualifications

• BS/BA in a science or engineering field with 4 years of GMP analytical testing experience, or MS/MA with 2 years.
• Experience in technical review, data interpretation and SOPs.
• Auditor/regulator interaction experience and strong written communication.

Responsibilities

• Provide technical oversight for QC analytical testing of bulk drug substance and drug product.
• Lead non-routine method transfer, validations, qualifications, verifications, and technical assessments.
• Coordinate quality activities across deviations, investigations, CAPAs, and change controls.

Skills

Technical oversight

Quality systems

Auditor liaison

Cross-functional leadership

GMP knowledge

Education

BS/BA in science/engineering

MS/MA in science/engineering

Tools

SOP writing

Quality systems

Job description

Boehringer Ingelheim GmbH in Fremont, CA is seeking an SR Specialist OR Specialist for QC Lab General duties. The role provides technical and quality leadership for non-routine method transfers, validations, verifications and assessments within a multi-product QC environment.

The position leads quality risk assessments, onboarding, training, and implementation of new equipment validation. It requires strong GMP experience, cross-functional collaboration and ability to interact with audits and