LL02-251008 TOP Documentation Specialist

Validation & Engineering Group-posted 2 months ago
Juncos, PR
101-250 employees
Personal and Laundry Services
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The TOP Documentation Specialist is responsible for the collection, review, organization, and delivery of Turnover Packages (TOPs) for all packaging line equipment, systems, and supporting utilities within a GMP-regulated biotechnology site. This role ensures that all engineering, commissioning, qualification, and vendor documents are accurate, complete, and compliant with site standards, FDA/EMA regulations, and project milestones for system handover to Operations and Quality.

  • Develop and maintain the TOP index, trackers, and matrix for all packaging lines and supporting systems (e.g., filling, labeling, cartoning, serialization, aggregation, utilities).
  • Coordinate with Engineering, Commissioning (Cx), Validation (CQV), Quality, and Construction teams to ensure all required records are submitted on time.
  • Collect and compile key documents, including: URS, BOD, design drawings, vendor manuals, material certifications, weld maps, FAT/SAT, IQ/OQ/PQ, calibration reports, EHS certifications, and training records.
  • Review all documents for accuracy, revision control, signatures, and GMP compliance before final handover.
  • Ensure all TOP documentation complies with GMP, FDA 21 CFR Part 11, GAMP 5, and data integrity requirements.
  • Support audit readiness by maintaining organized, retrievable, and secure records (electronic and hard copy).
  • Work with the Quality Unit to ensure final TOP approval and proper archiving into the sites document control system (e.g., Veeva, Documentum, or MasterControl).
  • Act as the central point of contact for document status, gaps, and deadlines for turnover deliverables.
  • Support engineering change controls, redlining of P&IDs/drawings, and transmittal logs as needed.
  • Prepare weekly progress reports on TOP completion percentages and outstanding items for project leadership.
  • Assist in the development of standard templates, workflows, and lessons learned to improve future turnover execution.
  • Associate or Bachelor's degree in Engineering, Technical Sciences, or Document Control/Information Management (or equivalent experience).
  • 3+ years of experience in TOP/document control in a GMP pharmaceutical, biotech, or regulated construction project environment.
  • Strong understanding of GMP documentation, Cx/Qx deliverables, validation protocols, and FDA/EMA compliance.
  • Proficiency with MS Excel/Word, PDF markup, and document control software (Veeva, MasterControl, Documentum, SharePoint).
  • Strong organizational skills with attention to detail, version control, and deadlines.
  • Experience supporting packaging line installation and turnover in biotech or pharmaceutical facilities.
  • Familiarity with Kneat or other e-CQV platforms for commissioning/qualification documentation.
  • Knowledge of LEED commissioning and sustainability-related documentation for energy and atmosphere credits.
  • Excellent communication and stakeholder coordination skills.
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