Inteldot has over 15 years in the life science industry with allocations a cross Puerto Rico, United Sates, Europe and Japan. This is a great opportunity for one of our leading clients in Puerto Rico.
Position Overview
We are seeking an experienced Documentation Coordinator to support documentation management and coordination activities within a Biotech Drug Substance Manufacturing Operation in Barceloneta, Puerto Rico. The selected candidate will be responsible for coordinating the lifecycle of controlled GMP documentation, supporting document review and approval workflows, maintaining document control systems, and ensuring compliance with regulatory and internal quality standards. This role requires strong organizational skills, attention to detail, and the ability to work closely with cross-functional teams including Manufacturing, Quality, Engineering, Validation, and Operations in a fast-paced regulated manufacturing environment.
Key Responsibilities- Coordinate the routing, review, approval, issuance, revision, and archival of controlled GMP documentation
- Manage document lifecycle activities for SOPs, batch records, forms, protocols, reports, and related manufacturing documentation
- Ensure documentation complies with GMP requirements, FDA regulations, and internal quality standards
- Support formatting, proofreading, consistency reviews, and document standardization efforts
- Track document status, due dates, periodic reviews, and approval timelines
- Collaborate with Subject Matter Experts (SMEs), Technical Writers, Manufacturing personnel, Quality Assurance, and Engineering teams to support documentation updates and implementation activities
- Maintain accurate records within document management systems and ensure version control compliance
- Assist with documentation metrics, reporting, and audit readiness activities
- Support document change control processes and ensure proper documentation traceability
- Participate in onsite meetings and coordination activities related to manufacturing documentation initiatives
- Associate’s or Bachelor’s degree in Science, Business Administration, Engineering, or related field preferred
- Minimum of 2 years of experience supporting document control or documentation coordination activities within biotech, pharmaceutical, medical device, or regulated manufacturing environments
- Experience handling controlled GMP documentation and document management processes
- Familiarity with GMP regulations, FDA documentation practices, and quality systems
- Strong organizational, administrative, and coordination skills
- Excellent written and verbal communication skills
- Strong attention to detail and ability to manage multiple priorities simultaneously
- Proficiency in Microsoft Office applications and electronic document management systems
- Ability to work independently and collaboratively in a fast-paced manufacturing environment
- Bilingual (English/Spanish)
- Experience supporting Drug Substance or biologics manufacturing operations
- Experience with document management systems such as Veeva, TrackWise, MasterControl, or similar platforms
- Experience supporting audit readiness, remediation, or continuous improvement initiatives
- Fully onsite position in Barceloneta, Puerto Rico
- Manufacturing and operational support environment
Skills Required
- Associate's or Bachelor's degree in Science, Business Administration, Engineering, or related field preferred
- Minimum of 2 years of experience supporting document control or documentation coordination activities within biotech, pharmaceutical, medical device, or regulated manufacturing environments
- Experience handling controlled GMP documentation and document management processes
- Familiarity with GMP regulations, FDA documentation practices, and quality systems
- Strong organizational, administrative, and coordination skills
- Excellent written and verbal communication skills
- Strong attention to detail and ability to manage multiple priorities simultaneously
- Proficiency in Microsoft Office applications and electronic document management systems
- Ability to work independently and collaboratively in a fast-paced manufacturing environment
- Bilingual (English/Spanish)
What We Do
Inteldot offers custom turn-key systems, systems integration, MES eBR configuration and integration solutions, business intelligence and analytics and technical staffing. We have been providing the Pharmaceutical, Manufacturing and Medical Device industries with services for a variety of applications since 2004
