QA C&Q Specialist

Validation & Engineering Group; Juncos (PR); On-site; USD 70,000 - 100,000; Full time

Job summary

Validation & Engineering Group is seeking a QA C&Q Specialist to support commissioning and qualification activities in regulated environments. The role focuses on reviewing C&Q documentation to ensure accuracy, completeness, and proper execution under GDP and GMP standards.

Ideal candidates have a science or engineering degree and at least 2 years in QA/Validation in pharma/biotech, with strong attention to detail and cross-functional collaboration.

Qualifications

• Bachelor's degree in Engineering, Science, Pharmacy or related field.
• 2 years in QA, Validation, Commissioning & Qualification in pharma/biotech.
• Experience reviewing validated docs in regulated environments.

Responsibilities

• Review C&Q docs for compliance with SOPs and standards.
• Verify documents are complete, accurate, and properly executed.
• Ensure GDP and GMP requirements are followed.
• Review qualification and commissioning docs and reports.
• Identify gaps and resolve with project teams.
• Provide QA feedback to C&Q and project personnel.
• Support document approval workflows.
• Maintain data integrity and traceability.
• Participate in meetings with QA, C&Q, Validation teams.
• Close observations related to documentation.

Skills

Document control

GxP knowledge

GDP

Quality Assurance

Regulatory compliance

Education

Bachelor's degree in Engineering/Science/Pharmacy

Tools

EDMS

Quality systems

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

• Bachelors 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 andor validation documentation in a regulated environment
• Knowledge of GMPGxP 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 andor 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 youre empowered to do your best work bold ideas thrive and real progress happens This isnt just a job its 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