GMP/GxP QA Liaison

QRC Group • Caguas, PR

23h

About The Position

The QA Liaison ensures the project’s deliverables meet all GMP/GxP, data integrity, and document control requirements. This role acts as a bridge between the project team and Quality Assurance team.

Requirements

• Extensive experience with GMP/GxP documentation processes and data integrity.
• Familiarity with manufacturing documentation types (batch records, SOPs, logbooks).
• Strong understanding of QA review processes and change management controls.
• Ability to work cross‑functionally with operations, QA, and documentation teams.
• Willing to travel US -East

Responsibilities

• Ensure redesigned documents comply with regulatory frameworks including GMP/GxP, ALCOA+, and internal SOPs.
• Validate controlled document release, versioning, approval workflows, and traceability.
• Participate in risk assessments, ensuring proposed changes meet quality expectations.
• Provide SMEs for data integrity, document retention, and regulated records processes.
• Oversee compliance during on‑site observations and stakeholder engagements.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed