QA C&Q Specialist

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. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

• QA C&Q Specialist

Position Summary

We are seeking a QA C&Q Specialist to support Quality Assurance activities within Commissioning & Qualification (C&Q) projects. This role will primarily focus on the review of C&Q documentation, ensuring that documents are accurate, complete, properly executed, and compliant with established procedures, quality standards, and project requirements.

The ideal candidate will have experience working in a regulated pharmaceutical or life sciences environment, with a strong understanding of GxP documentation practices and C&Q processes.

Key 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 Good Documentation Practices (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.

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 a related role within the pharmaceutical, biotechnology, or medical device industry.
• Experience reviewing technical and/or validation documentation in a regulated environment.
• Knowledge of GMP/GxP, Good Documentation Practices (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.
• Ability to work independently while collaborating effectively with cross-functional teams.

Preferred Experience

• Experience supporting C&Q documentation and qualification activities.
• Familiarity with equipment, utilities, facilities, or process qualification documentation.
• Experience working with electronic document management or quality systems.
• Knowledge of FDA and/or other applicable regulatory requirements.

Key Competencies

• Document review and quality control
• Procedural compliance
• Good Documentation Practices (GDP)
• Attention to detail
• Quality mindset
• Technical documentation
• Problem solving
• Cross-functional collaboration

At Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.

Excited to build something meaningful together? We look forward to hearing from you.

Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.