GMP QA Documentation Specialist II

PCI Pharma Services; San Diego (CA); On-site; USD 50,000 - 56,000; Full time

Job summary

PCI Pharma Services seeks a QA Documentation Associate II to coordinate the review and approval of SOPs, master batch records, and other GMP documents using an electronic document management system. You will work with Project Managers and SMEs to revise records and support archival tasks.

This full-time role requires 2–4 years in documentation or quality assurance, familiarity with cGMP, and proficiency with Microsoft Office.

Qualifications

• High School diploma or equivalent required; Associate degree preferred.
• 2–4 years of experience in documentation or quality assurance.
• Familiarity with cGMP guidelines.
• Proficient in Microsoft Office and data entry.
• Ability to work independently or in a team.
• Detail oriented with strong written and verbal communication.

Responsibilities

• Coordinate review and approval of GMP documentation using an electronic document management system.
• Work with Project Managers and SMEs to revise master batch records.
• Provide administrative support: scanning, maintaining spreadsheets, archival of documents.
• Monitor QA/QC databases for trending documentation.
• Issue batch records, lab notebooks, and logs for GMP production/testing.
• Facilitate client review and approval of documents.
• Maintain master copies and original production records.
• Ensure compliance with SOPs and maintain a GMP environment.

Skills

Detail oriented

Independent worker

Team collaboration

Verbal communication

Education

High School Diploma or equivalent

Associate degree preferred

Tools

Microsoft Office

Electronic document management system

Job description

PCI Pharma Services seeks a QA Documentation Associate II to coordinate the review and approval of SOPs, master batch records, and other GMP documents using an electronic document management system. You will work with Project Managers and SMEs to revise records and support archival tasks.

This full-time role requires 2–4 years in documentation or quality assurance, familiarity with cGMP, and proficiency with Microsoft Office.