Senior Analytical QA & QC Investigations Lead

Bachem Holding AG; Vista (CA); Presencial; USD 103.000 - 135.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Competitive pay

Annual performance bonus

Medical/Dental/Vision coverage

401(k) with employer contribution

Paid vacation, personal and sick days

Descripción de la vacante

Bachem Americas seeks a Sr. Analytical Quality Assurance Specialist to provide cGMP oversight across QC functions and analytical data integrity.

The role collaborates with QC on investigations, SOP development, and method validation, ensuring timely, compliant results and strong QA/QC documentation. The incumbent will lead reviews of stability, environmental monitoring, and analytical reports, while driving continuous improvement in laboratory systems and metrics, with a focus on audit readiness

Formación

• Bachelor’s degree in life sciences or related field.
• 8+ years in a cGMP environment.
• 5+ years working in Quality Assurance and/or Quality Control.
• 3+ years in Quality Control.
• 3+ years in the Pharmaceutical, Biopharmaceutical, or Medical Device industries.
• Strong applied knowledge of cGMP investigations, including deviations, OOS, and environmental excursions.
• Strong knowledge of Root Cause Analysis tools (6M, 5 Whys, Is/Is-Not).
• Proficient with QC analytical methodologies (HPLC, UHPLC, GC, Karl Fischer, FTIR).
• Experience with QA/QC documentation (method development, transfer, qualification, SOPs, stability reports).
• Experience with CAPA systems and data integrity.

Responsabilidades

• Support QC investigations (OOS/OOT/OOE, Deviations, System Suitability) and drive corrective actions.
• Author, revise, and approve SOPs, work instructions, and test methods with QC.
• Review method development/validation documents and supporting data.
• Oversee environmental monitoring, bioburden, endotoxin, water testing, and microbial ID testing.
• Review stability protocols/reports and ensure acceptance criteria are met.
• Provide quality oversight for QC studies from design to approval.
• Conduct laboratory walkthroughs for housekeeping, audit readiness, and data integrity.
• Oversee the Invalid Assay program and Environmental Monitoring trend reports.
• Promote risk-based investigation management and CAPA effectiveness.
• Support metrics/KPIs development and health authority/client inspections.

Conocimientos

cGMP investigations

HPLC/UHPLC

CAPA

Environmental monitoring

Root cause analysis

Change management

Data analysis

Method documentation

Team collaboration

GxP knowledge

Educación

Bachelor’s degree in life sciences

Herramientas

MasterControl

TrackWise

Veeva

Descripción del empleo

Bachem Americas seeks a Sr. Analytical Quality Assurance Specialist to provide cGMP oversight across QC functions and analytical data integrity.

The role collaborates with QC on investigations, SOP development, and method validation, ensuring timely, compliant results and strong QA/QC documentation. The incumbent will lead reviews of stability, environmental monitoring, and analytical reports, while driving continuous improvement in laboratory systems and metrics, with a focus on audit readiness