Senior QC Analyst & Analytical Methods SME

Boehringer Ingelheim Pharmaceuticals, Inc.; Fremont (CA); On-site; USD 56,000 - 83,000; Full time

Benefits offered by this job

Medical, dental, vision

Retirement savings plan

Paid time off

Job summary

Boehringer Ingelheim Pharmaceuticals, Inc. in Fremont, CA is seeking a Senior/Master QC Associate in the QC Lab General area. You will execute analytical testing, serve as SME for 3–5 methodologies, and support audits and method validation in a multi-product facility.

The role requires strong cGMP knowledge, data interpretation skills, and ability to train others while maintaining compliance with regulatory standards. A bachelor’s or master’s in a science/engineering field is preferred.

Qualifications

• Bachelor’s or higher in science/engineering with cGMP experience.
• Experience with analytical methodologies in biopharmaceuticals is preferred.
• Strong written and verbal communication skills.
• Ability to work with minimal supervision in a regulated environment.

Responsibilities

• Execute non-routine analytical testing; act as SME for multiple methods.
• Perform data review, interpretation, and trending of results.
• Prepare and maintain SOPs, forms, and test methods per cGMP/GDP.
• Train others and assist in audits and inspections.
• Coordinate method transfer/validation activities and CAPA tracking.

Skills

Analytical methods

cGMP knowledge

Technical review

Data interpretation

Audit readiness

QA documentation

Team collaboration

Education

Bachelor's degree in science/engineering

Master's degree in science/engineering (preferred)

Associate degree

High school diploma

Tools

Process control systems

Laboratory instrumentation

Job description

Boehringer Ingelheim Pharmaceuticals, Inc. in Fremont, CA is seeking a Senior/Master QC Associate in the QC Lab General area. You will execute analytical testing, serve as SME for 3–5 methodologies, and support audits and method validation in a multi-product facility.

The role requires strong cGMP knowledge, data interpretation skills, and ability to train others while maintaining compliance with regulatory standards. A bachelor’s or master’s in a science/engineering field is preferred.