QC Lab Specialist: Method Transfer & Compliance Lead

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

Job summary

Boehringer Ingelheim in Fremont, CA is seeking a QC/Analytical Scientist to oversee analytical testing of bulk drug substances and products in a multi‑product facility. You will lead method transfers, validate assays, and provide technical reviews within cGMP.

The role emphasizes quality, compliance, and continuous improvement, with opportunities to contribute during audits and to develop SOPs while collaborating across cross‑functional teams.

Qualifications

• BS/BA or MS/MA in a science or engineering field with relevant analytical testing experience.
• Experience with technical review, data analysis, and interpretation of scientific results.
• Familiarity with GMP/cGMP and quality system processes (SOPs, deviations, CAPAs).

Responsibilities

• Provide technical oversight and review QC analytical testing in a multi‑product facility.
• Lead routine method transfers, validations, and qualification activities as SME.
• Identify improvements to lab processes and ensure compliance with GMP.
• Document work according to cGMP and cGDP; maintain training and group trainings as SME.

Skills

Technical analysis

GMP knowledge

Auditing liaison

Data interpretation

Quality systems

Education

BS/BA in science or engineering

MS/MA in science or engineering

Tools

Computer-based systems

Job description

Boehringer Ingelheim in Fremont, CA is seeking a QC/Analytical Scientist to oversee analytical testing of bulk drug substances and products in a multi‑product facility. You will lead method transfers, validate assays, and provide technical reviews within cGMP.

The role emphasizes quality, compliance, and continuous improvement, with opportunities to contribute during audits and to develop SOPs while collaborating across cross‑functional teams.