QA Technical Operations Lead: cGMP & Quality Excellence

Bachem; Vista (CA); On-site; USD 98,000 - 135,000; Full time

Benefits offered by this job

Annual performance bonus

Medical/Dental/Vision coverage

401(k) plan with employer contribution

Paid vacation, personal and sick days

Job summary

Bachem Americas is seeking a Quality Assurance Technical Operations Specialist in Vista, CA to enhance quality oversight, regulatory compliance, and internal procedures across API manufacturing processes.

The role focuses on evaluating quality systems, managing open quality events, and driving improvements with cross-functional teams. Requires 8+ years in a cGMP environment and deep QA experience.

Qualifications

• Bachelor's degree required for this role.
• Degree in Biological Sciences, Chemistry, or Engineering preferred.
• Minimum 8 years in a cGMP environment.
• Minimum 5 years in Quality Assurance.
• Experience in Pharmaceutical, Biopharmaceutical, or Medical Device industries preferred.
• Strong knowledge of cGMP investigations, including deviations and OOS.
• Proficient with CAPA, change management, and risk assessments.
• Experience with QA management systems (MasterControl, TrackWise, Veeva).

Responsibilities

• Evaluate global harmonization and local requirements to identify areas of improvement.
• Collaborate with Operations to drive corrective actions from quality events.
• Develop, maintain, analyze, and communicate Quality Event Metrics and KPIs.
• Develop and deliver focused training events for Operations personnel on cGMP compliance.
• Lead risk management initiatives across the site.
• Identify workflows to increase efficiency without compromising compliance.
• Maintain qualification for QA roles including document review and change management.
• Support client and health authority audits and inspections.

Skills

cGMP investigations

Root Cause Analysis

Technical writing

CAPA

Change management

Data analysis

Quality metrics

Collaboration

Training delivery

Problem solving

Interview techniques

Fishbone

5 Whys

Education

Bachelor's degree (required)

Bachelor's in Biological Sciences/Chemistry/Engineering preferred

Tools

MasterControl

TrackWise

Veeva

Job description

Bachem Americas is seeking a Quality Assurance Technical Operations Specialist in Vista, CA to enhance quality oversight, regulatory compliance, and internal procedures across API manufacturing processes.

The role focuses on evaluating quality systems, managing open quality events, and driving improvements with cross-functional teams. Requires 8+ years in a cGMP environment and deep QA experience.