QA C&Q Specialist

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

Current job opportunities are posted here as they become available.

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.
• Document review and quality control
• Procedural compliance
• Good Documentation Practices (GDP)
• 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.

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.