QC Lab Specialist (General) - Onsite Fremont

Boehringer Ingelheim Pharmaceuticals, Inc.; Fremont (CA); Vor Ort; USD 88.000 - 132.000; Vollzeit

Benefits dieser Stelle

Discretionary bonus

Relocation assistance

Medical, dental & vision benefits

Zusammenfassung

Boehringer Ingelheim Pharmaceuticals, Inc. is seeking a Specialist, QC Lab General, onsite in Fremont, CA. The role focuses on overseeing QC testing, method transfers, and ensuring compliance across multiple analytical areas in a fast-paced, multi-product facility.

The position emphasizes technical leadership, data interpretation, and collaboration with cross-functional teams to drive quality improvements and maintain cGMP standards. Competitive compensation and benefits apply.

Qualifikationen

• BS/BA in science or engineering with 4 years of GMP analytical testing experience or
• MS/MA in science or engineering with 2 years of GMP analytical testing experience.
• Experience with technical review, data interpretation and trends.
• Experience interacting with auditors/regulators and communicating within subject matter expertise.
• Experience with SOPs, methods, and work instructions.
• Knowledge of quality systems (CAPA, deviations, OOX, CC, change controls).

Aufgaben

• Provides technical oversight and reviews QC analytical testing in a multi-product facility.
• Lead routine/ platform method transfers, validations, verifications and related technical assessments.
• Ensure quality/compliance activities for new or non-routine tests, specs, and SOPs.
• Coordinate and implement improvements to lab processes and compliance.
• Represent QC in audits and lead group trainings on complex topics.

Kenntnisse

Technical review

Analytical testing

Auditing interaction

Quality systems

CAPA

SOP writing

Ausbildung

BS/BA in science or engineering

MS/MA in science or engineering

Jobbeschreibung

Boehringer Ingelheim Pharmaceuticals, Inc. is seeking a Specialist, QC Lab General, onsite in Fremont, CA. The role focuses on overseeing QC testing, method transfers, and ensuring compliance across multiple analytical areas in a fast-paced, multi-product facility.

The position emphasizes technical leadership, data interpretation, and collaboration with cross-functional teams to drive quality improvements and maintain cGMP standards. Competitive compensation and benefits apply.