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FITS, LLC Linkedin · Posted 1mo ago

Document Control Specialist – Engineering Capital Group

Cidra, Cidra, Puerto Rico

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Indexed description

For Documentation Support services. 

WHAT MAKES YOU A FIT: 

The Technical Part:

  • Bachelor’s Degree with a minimum of 2 years of experience in document control within the Pharmaceutical or Medical Device industry.
  • Bilingual, Spanish and English 
  • Shift: Administrative and according to business needs. 
  •  Experience in:
    • Standard Operating Procedures (SOPs)
    • P&IDs 
    • Technical Drawings
    • GMP and GDP 

The Personality Part:

  • Our Next Piece is someone who treats everyone they meet like family, especially our resources, clients and team members. In other words, being a customer service pro is one your (many) talents. Being the Piece means you're full of bright ideas and eager to innovate, always bringing top-quality results to the table. Are you ready to Be The Piece?  

AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)

  • Analyze, author, and revise complex technical documentation, ensuring all procedures and SOPs meet rigorous industry standards.
  • Manage controlled documentation for the Capital Projects Team, overseeing protocols, change controls, and meeting minutes to ensure regulatory alignment.
  • Oversee the routing and approval workflows for engineering documents (submittals, PIFs, ePIPs, and drawings) to enhance traceability and reduce turnaround times.
  • Maintain and audit operational records, including logbooks, CMMS work orders, and safety forms, to ensure data integrity and procedural compliance.
  • Prepare and organize documentation for internal and external audits to strengthen organizational readiness and alignment with Quality systems.
  • Monitor ePIP system approvals, ensuring timely processing and adherence to established recordkeeping standards.
  • Ensure all capital documentation activities comply with cGMP and global quality requirements.
  • Administer the secure receipt, classification, and filing of all designated controlled documents.
  • Maintain comprehensive logs of all document activities, including tracking updates and removals.
  • Facilitate timely document retrieval and distribution for internal and external stakeholders.
  • Execute accurate data entry into specialized computer systems and adhere to strict document retention policies.
  • Demonstrate advanced proficiency in Microsoft Office Suite (Word and Excel) to manage workloads and prioritize tasks efficiently.

WHO WE ARE:

We are a Service Provider company different from the rest. We pride ourselves in how we treat the most important piece of our company's puzzle: you! We integrate Engineering, Construction, Maintenance, Utilities and Specialized Technical services across the Island (and in the US as well!). Our company is flexible, family-oriented and focused on our resources' well-being, while providing our Pharmaceutical, Medical Device and Manufacturing industry clients with top-notch quality talent. We're FITS! 

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