Biilingual Documentation Specialist Laboratory
5TH HQ, Florida, NY, United States
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
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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
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