GMP Documentation & Turnover Specialist

QRC Group; Manatí (PR); On-site; USD 70,000 - 100,000; Full time

Job summary

QRC Group in Manatí, Puerto Rico seeks a GMP Documentation Specialist to support the C&Q team on a pharmaceutical lab renovation. You will work directly with the Construction Manager and General Contractor to ensure GMP documentation is built correctly from the start of construction, preventing gaps at turnover.

Responsibilities include guiding the contractor on GMP documentation throughout construction, overseeing test certifications, Mechanical Completion, and Turnover Package content, and

Qualifications

• 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.

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.

Skills

GMP documentation

Document control

Advanced Excel

Organization

Follow-up

Education

Associate’s or Bachelor’s degree in Engineering, Science or a related field

Tools

Maximo CMMS

Job description

QRC Group in Manatí, Puerto Rico seeks a GMP Documentation Specialist to support the C&Q team on a pharmaceutical lab renovation. You will work directly with the Construction Manager and General Contractor to ensure GMP documentation is built correctly from the start of construction, preventing gaps at turnover.

Responsibilities include guiding the contractor on GMP documentation throughout construction, overseeing test certifications, Mechanical Completion, and Turnover Package content, and