Senior QA Specialist: GMP Compliance & Audits

Bachem Holding AG; Vista (CA); On-site; USD 97,000 - 134,000; Full time

Job summary

Bachem Americas in Vista, California is seeking a Sr. Quality Assurance Specialist to advance GMP systems, review documentation, and guide QA activities across sites.

You will lead real time batch record reviews, support audits, improve quality systems, and train teams on GMP practices. A strong background in organic chemistry or related field and 4–6 years of GMP QA experience are required, including ISO7/ISO8 environments.

Qualifications

• Bachelor's in organic chemistry or related field required or
• Master's in organic chemistry or related field preferred
• 5+ years GMP manufacturing experience required
• 7 years GMP exp with QA document control/validation preferred
• 4-6 years QA experience required
• Experience with ISO7/ISO8 environments and real time batch review
• Experience with internal audits and regulatory agencies preferred
• Excellent written and oral communication skills
• MS Office skills: Word, Excel, PowerPoint

Responsibilities

• Perform duties pertaining to QA specialist levels I–III and more.
• Support real time batch record review and electronic release decisions.
• Suggest improvements to quality systems and SOPs using LEAN GMP.
• Review and approve GMP documentation including BPRs, protocols, reports.
• Analyze, trend data and assist in investigations (OOS) and changes.
• Collaborate with other sites to close quality records and documents.
• Lead GMP audits and provide guidance to other departments.
• Assist with customer/authority audits and SOP writing.

Skills

MS Office suite

Communication skills

LEAN GMP knowledge

Education

Bachelor's Degree in organic chemistry or related field

Master's Degree in organic chemistry or related field preferred

Bachelor's Degree in a science related field + 5 years GMP exp

Associate's Degree in a science related field + 7 years GMP exp

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Job description

Bachem Americas in Vista, California is seeking a Sr. Quality Assurance Specialist to advance GMP systems, review documentation, and guide QA activities across sites.

You will lead real time batch record reviews, support audits, improve quality systems, and train teams on GMP practices. A strong background in organic chemistry or related field and 4–6 years of GMP QA experience are required, including ISO7/ISO8 environments.