QA C&Q Specialist - GDP & Validation Docs Expert

Validation & Engineering Group, Inc.; Juncos (PR); On-site; USD 70,000 - 110,000; Full time

Job summary

Validation & Engineering Group, Inc. seeks a QA C&Q Specialist to support Commissioning & Qualification activities.

This role focuses on reviewing C&Q documentation to ensure accuracy, proper execution, and compliance with procedures, quality standards, and project requirements. The ideal candidate has a bachelor’s degree in a related field and 2+ years in QA/Validation/C&Q within pharma, biotech, or medical devices, with strong attention to detail and collaboration across

Qualifications

• Experience reviewing technical and/or validation documentation in a regulated environment.
• Knowledge of GMP/GxP, GDP, and quality systems.
• Ability to interpret and apply SOPs and established procedures.
• Strong attention to detail and organizational skills.
• Excellent written and verbal communication skills.

Responsibilities

• Review C&Q documentation for compliance with procedures, standards, and project requirements.
• Verify that documents are complete, accurate, and properly formatted and executed.
• Ensure C&Q activities and documentation follow SOPs, protocols, procedures, and quality requirements.
• Review qualification and commissioning documents, including protocols, reports, forms, and supporting documentation.
• Identify documentation gaps, inconsistencies, or deviations and work with project teams to resolve them.
• Provide QA feedback and recommendations to C&Q and project personnel.
• Support documentation practices and approval workflows throughout the project lifecycle.
• Maintain data integrity, traceability, and GDP.
• Participate in cross-functional meetings with C&Q, Engineering, Validation, and Quality teams.

Skills

GxP knowledge

GDP experience

Documentation review

Quality systems

Cross-functional teamwork

SOP interpretation

Attention to detail

Education

Bachelor's degree in Engineering, Science, Pharmacy, Quality

Tools

Electronic document management (EDMS)

Job description

Validation & Engineering Group, Inc. seeks a QA C&Q Specialist to support Commissioning & Qualification activities.

This role focuses on reviewing C&Q documentation to ensure accuracy, proper execution, and compliance with procedures, quality standards, and project requirements. The ideal candidate has a bachelor’s degree in a related field and 2+ years in QA/Validation/C&Q within pharma, biotech, or medical devices, with strong attention to detail and collaboration across