GMP Documentation Specialist – Pharma

Siegfried AG; Irvine (CA); On-site; USD 80,000 - 110,000; Full time

Job summary

Siegfried AG in Irvine, CA seeks a documentation and quality/compliance professional to ensure GMP documentation and batch records are complete and accurate.

You will collaborate across manufacturing and QA, review investigations and deviations, write CAPA actions, and help ensure on-time product release and regulatory compliance.

Strong attention to detail, knowledge of cGMPs, and ability to work with multiple departments are essential in this role.

Qualifications

• Excellent understanding of cGMPs, GDPs and their importance in Quality Control/Batch Record review.
• Proficient computer skills and database familiarity to manage records and reports.
• Ability to interface with all levels of management and stakeholders.

Responsibilities

• Review batch records and related documents for compliance and accuracy.
• Investigate deviations and prepare CAPA-related documentation and reports.
• Coordinate with manufacturing, planning and QA for product release and documentation.
• Assist in writing and updating SOPs to reflect current practices.
• Monitor regulatory guidance and ensure adherence across processes.

Skills

cGMPs GDPs

Regulatory knowledge

Documentation

Problem solving

Team collaboration

Education

Science degree

Tools

ERP systems

Job description

Siegfried AG in Irvine, CA seeks a documentation and quality/compliance professional to ensure GMP documentation and batch records are complete and accurate.

You will collaborate across manufacturing and QA, review investigations and deviations, write CAPA actions, and help ensure on-time product release and regulatory compliance.

Strong attention to detail, knowledge of cGMPs, and ability to work with multiple departments are essential in this role.