What are the responsibilities and job description for the Biilingual Documentation Specialist – Laboratory position at 5TH HQ?
5th HQ Staffing is currently recruiting for a Bilingual Documentation Specialist for a laboratory environment. This position plays a key role in supporting Quality Assurance and ensuring compliance with cGLP/GMP regulations and company policies.
Job Summary:
The Documentation Specialist is responsible for maintaining accurate laboratory documentation, supporting stability programs, assisting with finished product release, and ensuring all records are complete, compliant, and properly controlled.
Location: Davie, FL
Schedule: Monday – Friday | 8:30 AM – 5:00 PM
Pay Rate: $23.00 per hour
Key Responsibilities:
• Comply with all cGLP/GMP regulations, laboratory SOPs, safety requirements, and company policies
• Maintain laboratory documentation, records, and notebooks according to SOP and cGLP requirements for the stability program
• Create stability protocols and generate quotes for new stability clients
• Maintain knowledge of physical testing procedures according to USP standards
• Manage documentation related to samples entering the stability program, samples in stability chambers, and stability protocol schedules
• Oversee documentation for samples sent to external laboratories
• Develop, generate, and edit controlled documents including Certificates of Analysis, reports, laboratory notebooks, and physical and chemist records (supporting QA Finished Product Release)
• Review and revise packing lists from the packing department to support QA Finished Product Release
• Review quality documentation to support release or rejection of finished products
• Process documentation in a timely manner to avoid operational disruptions
• Review batch records thoroughly to ensure completeness and accuracy prior to release
• Maintain secure storage and organization of documentation files and databases
• Perform additional clerical duties as assigned by the Supervisor
Qualifications:
• 1–3 years of laboratory experience required
• Bilingual English and Spanish required
• Knowledge of GMP regulations required
• Computer literate
• Strong attention to detail
• Previous experience in production or Quality Control preferred
Salary : $23