QC Lab Specialist - Method Transfer & Validation Lead

University Industry Demonstration Partnership; Fremont (CA); On-site; USD 75,000 - 122,000; Full time

Benefits offered by this job

Relocation assistance

Job summary

Boehringer Ingelheim in Fremont, CA seeks a QC Technical Lead to drive non-routine method transfers, validations, and qualifications within a GMP framework. You will act as a QC SME, lead cross-functional teams, and uphold quality systems across the QC department.

The role involves proposing and implementing improvements, maintaining regulatory compliance, and guiding teams through deviations, CAPAs and audits while supporting training and development of staff.

Qualifications

• Six years of analytical testing in GMP or equivalent.
• Experience authoring SOPs and methods.
• Strong data interpretation and technical review skills.
• Excellent communication and presentation abilities.
• Subject matter expert in analytical methodologies.

Responsibilities

• Technical and Quality lead for non-routine method transfers, validations, qualifications, verifications, and technical assessments.
• Group rep on equipment qualifications for new and novel technology; lead for quality risk assessment and onboarding of new equipment validation.
• Documents work according to cGMP and cGDP; ensures compliance across QC.
• Lead investigations (OOS, CAPAs) and cross-functional project teams; support audits.
• Mentor and train technicians; develop training curricula and SME capability.

Skills

Technical review

Analytical methods

Quality Systems

Auditor liaison

Education

Bachelor's degree in science/engineering

Master's degree in science/engineering

PhD in science/engineering

Tools

Process control systems

Job description

Boehringer Ingelheim in Fremont, CA seeks a QC Technical Lead to drive non-routine method transfers, validations, and qualifications within a GMP framework. You will act as a QC SME, lead cross-functional teams, and uphold quality systems across the QC department.

The role involves proposing and implementing improvements, maintaining regulatory compliance, and guiding teams through deviations, CAPAs and audits while supporting training and development of staff.