GMP Documentation Specialist
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Summary
QRC Group is hiring a GMP Documentation Specialist in Manati, Puerto Rico to support a C&Q team during a laboratory renovation at a pharmaceutical manufacturing site — guiding contractors on GMP documentation, overseeing turnover packages, and managing CMMS assets, job plans and spare parts (Maximo preferred). Requires 3+ years of GMP document-control experience and bilingual English/Spanish.
QRC Group is seeking a GMP Documentation Specialist to support the C&Q team on a laboratory renovation at a pharmaceutical manufacturing site. The role works directly with the Construction Manager and General Contractor so that GMP documentation is built correctly from the start of construction, preventing gaps at system turnover.
Responsibilities
- Guide the contractor on GMP documentation requirements throughout construction.
- Oversee test certifications, Mechanical Completion documentation and Turnover Package (TOP) content and readiness.
- Monitor documentation progress from early construction and close gaps before turnover.
- Create CMMS service requests for new equipment, instruments and assets, and develop or revise job plans.
- Request spare parts from contractors and track them until quotes are received and loaded in CMMS.
- Maintain documentation trackers and report status to the CQV Lead.
Requirements
- Associate’s
or Bachelor’s degree in Engineering, Science or a related field.
- 3+
years in GMP documentation or document control on pharmaceutical capital
projects.
- Experience
with turnover packages, mechanical completion and contractor
documentation.
- CMMS
experience (Maximo preferred): asset setup, job plans and spare parts.
- Strong
organization and follow-up skills; advanced Excel.
- Fully
bilingual (English / Spanish).