Senior Analytical QA & Compliance Leader

Bachem Americas, Inc.; Vista (CA); Presencial; USD 98.000 - 135.000; Jornada completa

Descripción de la vacante

Bachem Americas, Inc. seeks a Sr. Analytical Quality Assurance Specialist to serve as a technical liaison between Quality Control and Quality Assurance.

This role ensures cGMP compliance for QC data, lab results, and documentation through collaboration and continuous improvement of laboratory systems. The candidate will lead investigations, author SOPs, review methods, and oversee environmental monitoring, stability data, and CAPA.

Formación

• Bachelor's degree in life sciences or related field.
• 8+ years in a cGMP environment.
• 5+ years in Quality Assurance and/or Quality Control.
• 3+ years in Quality Control.
• 3+ years in the Pharmaceutical, Biopharmaceutical, or Medical Device industries.
• Strong knowledge of cGMP investigations (deviations, OOS, environmental excursions).
• Proficient with CAPA, including effectiveness checks.
• Experience interpreting microbiological data (bioburden, endotoxin, environmental monitoring).
• Familiar with Change Management governance and QA systems (MasterControl, Trackwise, Veeva).
• Proven problem-solving and collaboration skills.

Responsabilidades

• Support QC investigations (OOS/OOT/OOE, deviations) and drive corrective actions.
• Author, revise, and approve SOPs, work instructions, and test methods.
• Review method development/validation documents and associated data.
• Ensure environmental monitoring, bioburden, endotoxin, and microbial testing compliance.
• Review stability protocols and reports to meet cGMP requirements.
• Provide quality oversight for QC studies from design to approval.
• Conduct laboratory walkthroughs to ensure safety, data integrity, and compliance.
• Oversee Invalid Assay program and environmental monitoring trend reviews.
• Drive risk-based investigations and data analysis within QA functions.
• Support client audits and inspections as required.

Conocimientos

cGMP investigations

Root Cause Analysis

CAPA

data interpretation

Quality Metrics

QA/QC experience

collaboration

problem solving

bioburden/environmental monitoring

Quality Management Systems

Educación

Bachelor's degree in life sciences or related field

Herramientas

MasterControl

Trackwise

Veeva

Descripción del empleo

Bachem Americas, Inc. seeks a Sr. Analytical Quality Assurance Specialist to serve as a technical liaison between Quality Control and Quality Assurance.

This role ensures cGMP compliance for QC data, lab results, and documentation through collaboration and continuous improvement of laboratory systems. The candidate will lead investigations, author SOPs, review methods, and oversee environmental monitoring, stability data, and CAPA.