QA Operations Specialist - GMP & Quality Improvements

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

Benefits offered by this job

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 to strengthen quality oversight across API manufacturing. You will collaborate with QA, QC, Manufacturing, Process Development, Engineering, Validation, and Supply Chain to drive improvements in quality systems and procedures.

You will manage quality events, deviations, CAPAs, change controls, and risk assessments while maintaining qualifications in key QA roles. Strong writing and training skills are essential.

Qualifications

• Bachelor's Degree required; biological sciences, chemistry, or engineering preferred.
• At least 8 years in a cGMP environment.
• At least 5 years in Quality Assurance.
• Experience in the Pharmaceutical, Biopharmaceutical, or Medical Device industries preferred.
• Strong cGMP investigations knowledge (deviations, OOS, environmental excursions).
• Proficient with CAPA, change management, risk management.
• Strong technical writing capabilities.
• Proactive, self-starter with willingness to seek guidance when required.
• Collaborates across QA, QC, Manufacturing, Engineering, and Supply Chain.

Responsibilities

• Evaluate global harmonization and local requirements and rewrite SOPs and work instructions.
• Drive corrective actions from quality events with coaching to ensure timely completion.
• Develop and communicate Quality Event Metrics and KPIs (Deviation, Change, CAPA, Risk).
• Develop and deliver focused trainings for Operations personnel on cGMP compliance.
• Lead risk management initiatives to drive preventive actions site-wide.
• Identify workflows to improve efficiency while maintaining cGMP compliance.
• Support client and health authority requests, site visits, audits, and inspections.

Skills

cGMP knowledge

Root Cause Analysis

Technical writing

CAPA

Change Management

Data analysis

Cross-functional collaboration

Training

Audit support

Quality Metrics

Education

Bachelor's Degree in Biological Sciences, Chemistry, or Engineering

Bachelor's Degree in a related field

Tools

MasterControl

Trackwise

Veeva

Job description

Bachem Americas is seeking a Quality Assurance Technical Operations Specialist to strengthen quality oversight across API manufacturing. You will collaborate with QA, QC, Manufacturing, Process Development, Engineering, Validation, and Supply Chain to drive improvements in quality systems and procedures.

You will manage quality events, deviations, CAPAs, change controls, and risk assessments while maintaining qualifications in key QA roles. Strong writing and training skills are essential.