Biilingual Documentation Specialist – Laboratory

5TH HQ

Biilingual Documentation Specialist – Laboratory

Davie, FL
Full Time
Paid
  • Responsibilities

    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