GMP Documentation & Quality Records Specialist

Siegfried; Irvine (CA); On-site; USD 78,000 - 88,000; Full time

Benefits offered by this job

Medical, Dental, Vision

FSA & HSA Options

Life Insurance

Disability (Short & Long Term)

Pet Insurance

Paid Time Off

401K

Job summary

Siegfried in Irvine, CA seeks a Quality Documentation Specialist to ensure GMP compliance across manufacturing records, investigations and related documents.

You will maintain batch release data, update SOPs, coordinate with Planning/QA, perform investigations, CAPAs, and review ERP transactions while applying FDA guidance.

Strong cGMP knowledge and clear written/verbal communication are essential; target salary range is $78,000 - $88,000.

Qualifications

• Excellent understanding of cGMPs, GDPs and their importance in Quality Control/Batch Record review.
• Computer literacy and database management.
• Exercise judgment in developing practices, techniques and evaluation criteria.
• Good oral, team and problem solving and basic math skills.
• Initiative and manual dexterity.
• Interface with all levels of management, peers and subordinates.
• Remain calm under pressure and communicate clearly with customers and regulators.
• Written and verbal skills; fluent in applying regulatory guidance to compliance.

Responsibilities

• Document manufacturing activities to ensure GMP compliance and proper investigations.
• Generate weekly status reports for product release and manufacturing status.
• Assist Supervisors to write/update SOPs and ensure GMP adherence.
• Coordinate production release with Planning and Product Release Departments.
• Conduct hands-on investigations and write investigations and customer complaints.
• Evaluate deviations, escalate to a Process Expert, and monitor CAPAs.
• Monitor CAPAs for completion and effectiveness.
• Review ERP transactions for compliance and timely execution.
• Prioritize work and meet deadlines; collaborate with management as needed.
• Understand FDA regulations and apply them to compliance.
• Review Batch Records for Commercial Distribution and related documents.

Skills

cGMPs & GDPs

Quality Control

Problem solving

Written & verbal communication

Regulatory guidance

Team collaboration

Attention to detail

Data interpretation

Safety awareness

Education

Science degree

Job description

Siegfried in Irvine, CA seeks a Quality Documentation Specialist to ensure GMP compliance across manufacturing records, investigations and related documents.

You will maintain batch release data, update SOPs, coordinate with Planning/QA, perform investigations, CAPAs, and review ERP transactions while applying FDA guidance.

Strong cGMP knowledge and clear written/verbal communication are essential; target salary range is $78,000 - $88,000.