QA C&Q Specialist: Documentation & Compliance Lead

Veg Group; Juncos (PR); On-site; USD 70,000 - 90,000; Full time

Job summary

Validation & Engineering Group, Inc. seeks a QA C&Q Specialist to support quality assurance activities within Commissioning & Qualification projects, focusing on review of C&Q documentation to ensure accuracy, completeness, and compliant execution.

The ideal candidate has experience in regulated pharmaceutical or life sciences environments, with knowledge of GMP/GxP, GDP and data integrity, and strong attention to detail.

Qualifications

• Bachelor's degree in Engineering, Science, Pharmacy, Quality, or a related field preferred.
• 2+ years of experience in Quality Assurance, Validation, Commissioning & Qualification, or related role within life sciences.
• 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 approved procedures, standards, and project requirements.
• Verify that documents are complete, accurate, and properly formatted and executed.
• Ensure C&Q activities and documentation follow applicable 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.
• Ensure appropriate documentation practices are followed throughout the project lifecycle.
• Support document approval and review workflows in accordance with established procedures.
• Maintain a strong focus on data integrity, traceability, and GDP.
• Participate in meetings and discussions with C&Q, Engineering, Validation, and Quality teams as needed.
• Support the resolution and closure of documentation-related observations or findings.

Skills

2+ years experience

Attention to detail

Communication skills

Education

Bachelor's degree in Engineering, Science, Pharmacy, Quality, or related field

Tools

Electronic document management

Job description

Validation & Engineering Group, Inc. seeks a QA C&Q Specialist to support quality assurance activities within Commissioning & Qualification projects, focusing on review of C&Q documentation to ensure accuracy, completeness, and compliant execution.

The ideal candidate has experience in regulated pharmaceutical or life sciences environments, with knowledge of GMP/GxP, GDP and data integrity, and strong attention to detail.