Senior QA Specialist — Document Control & GMP

Bachem Holding AG; Vista (CA); On-site; USD 87,000 - 120,000; Full time

Job summary

Bachem Holding AG is seeking a Quality Assurance Specialist III with emphasis on Document Control to support GMP documentation, data analysis, and QA guidance. The role involves real-time batch record reviews, SOP improvements, and audits across sites to strengthen quality systems and regulatory compliance.

Ideal candidates will have 5+ years in GMP manufacturing, strong communication skills, and a background in organic chemistry or related fields.

Qualifications

• Bachelor’s degree in organic chemistry or related field required.
• Master’s degree in organic chemistry or related field preferred.
• 5+ years’ experience in a GMP manufacturing setting required.
• 4–6 years experience in GMP document control, validation, qualification and calibration required.
• 4–6 years experience in ISO7/ISO8 control environment and batch review required.
• Excellent written and oral communication skills.

Responsibilities

• Perform duties of QA specialist I and II in addition to listed tasks.
• Support real time batch record review and electronic batch release decisions.
• Suggest improvements in quality systems and SOPs using LEAN GMP approaches.
• Review and approve GMP documentation (BPRs, validation protocols, data, reports).
• Review, analyze, and trend data to extract relevant information.
• Collaborate with other functions/sites to close quality records and approve changes.

Skills

GMP knowledge

Document control

Quality audits

Data analysis

SOP development

Education

Bachelor's in chemistry

Master's in chemistry

Associate's in science

Tools

Microsoft Word

Excel

PowerPoint

Job description

Bachem Holding AG is seeking a Quality Assurance Specialist III with emphasis on Document Control to support GMP documentation, data analysis, and QA guidance. The role involves real-time batch record reviews, SOP improvements, and audits across sites to strengthen quality systems and regulatory compliance.

Ideal candidates will have 5+ years in GMP manufacturing, strong communication skills, and a background in organic chemistry or related fields.