Quality Assurance Auditor

N&CS Consulting Group Inc.; Aibonito (PR); On-site; USD 65,000 - 90,000; Full time

Job summary

N&CS Consulting Group Inc. in Puerto Rico is seeking a Quality Assurance Auditor for a contract, on-site role based in Aibonito. You will plan and conduct quality audits in regulated manufacturing and laboratory environments.

You will review documentation, assess compliance with procedures, and identify nonconformities. The position requires collaborating with cross-functional teams and contributing to continual improvement of quality systems.

Qualifications

• Experience auditing in pharma, biotech, biologics, or medical devices.
• Knowledge of FDA, EMA, GMP, ISO guidelines is highly beneficial.
• Strong analytical and documentation skills with attention to detail.
• Bachelor's degree preferred; equivalent practical experience accepted.

Responsibilities

• Plan, perform internal and external audits.
• Review documentation and records for compliance.
• Identify nonconformities and report findings.
• Recommend CAPA and verify effectiveness.
• Collaborate with cross-functional teams on-site in Aibonito.
• Support continuous improvement and quality management systems.

Skills

Quality Auditing

Documentation

Regulatory knowledge

Cross-functional collaboration

Education

Bachelors in science/engineering or related

Job description

Company Description N&CS Consulting Group Inc. is a full-service validation and regulatory compliance firm supporting pharmaceutical, biotechnology, biologics, and medical device organizations. The team consists of experienced industry professionals who deliver projects on time and within budget, using practical approaches to validation and strong customer service. The company focuses on understanding each client’s unique needs, defining clear project requirements, and tailoring services to provide cost-effective solutions. Emphasis is placed on innovative thinking that improves service quality and reduces engineering time, design rework, and overall project duration. Additional information about N&CS Consulting Group Inc. is available at www.nandcsgroup.com.
Role Description The Quality Assurance Auditor is a contract, on-site role based in Aibonito, responsible for conducting quality audits in regulated manufacturing and laboratory environments. Daily activities include planning and performing internal and external audits, reviewing documentation and records, and assessing compliance with company procedures, regulatory standards, and industry guidelines. The auditor will identify nonconformities, prepare clear audit reports, recommend corrective and preventive actions, and follow up to verify implementation and effectiveness. The role also involves collaborating with cross-functional teams, supporting continuous improvement initiatives, and contributing to the maintenance of quality management systems and best practices.
Qualifications

• Candidates should possess skills in Quality Auditing and Auditing to plan, execute, and document compliance assessments.
• Candidates should possess skills in Quality Control and Quality Assurance to evaluate processes, products, and documentation against defined standards.
• Candidates should possess skills in Quality Management to support quality systems, continuous improvement, and regulatory compliance.
• Experience in pharmaceutical, biotechnology, biologics, or medical device industries, with knowledge of relevant regulations and guidelines (e.g., FDA, EMA, GMP, ISO) is highly beneficial.
• Strong analytical, problem-solving, and documentation skills, with attention to detail and the ability to present findings clearly.
• Ability to work collaboratively on-site in Aibonito, manage multiple audits and priorities, and maintain professional objectivity.
• A bachelor’s degree in a scientific, engineering, or related discipline, or equivalent practical experience in quality or compliance, is preferred.