Documentation Specialist

Flexible & Integrated Technical Services, LLC • Añasco, PR

1d • Onsite

About The Position

The Documentation Specialist will provide documentation services in the Engineering/Manufacturing, Quality, and Metrology areas. This role is crucial for supporting regulated documentation, with a preference for calibration records, within GMP/GDP environments. Key aspects include knowledge of Quality Systems, documentation control, and assisting with internal and external audits. The specialist will collaborate cross-functionally with Metrology, Quality, and Engineering/Manufacturing teams, requiring strong attention to detail to ensure data integrity, traceability, and compliance with regulatory requirements. The hiring company is a Service Provider that integrates Engineering, Construction, Maintenance, Utilities, and Specialized Technical services, focusing on employee well-being and providing quality talent to clients in the Pharmaceutical, Medical Device, and Manufacturing industries.

Requirements

• Associate degree in Life Sciences or related field.
• Previous exposure within the Pharmaceutical or Medical Devices industry.
• Bilingual, Spanish and English (good communication).
• Experience in supporting regulated documentation, preferably calibration records, in GMP/GDP environments.
• Knowledge of Quality Systems, including documentation control and support for internal and external audits.
• Ability to collaborate cross‑functionally with Metrology, Quality, and Engineering/Manufacturing teams.
• Strong attention to detail with the ability to ensure data integrity, traceability, and compliance with regulatory requirements.

Responsibilities

• Support calibration documentation activities.
• File and organize calibration documents and certificates, both physical and electronic.
• Verify that documentation is complete, legible, and compliant with GDP (Good Documentation Practices) requirements.
• Maintain control and traceability of calibration records.
• Identify and report missing documentation or discrepancies to the responsible area.
• Assist in the preparation of documentation for internal and external audits.
• Ensure compliance with Quality, Confidentiality, and Data Integrity policies.

Benefits

• Our company is flexible, family-oriented and focused on our resources' well-being.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Associate degree