What are the responsibilities and job description for the Documentation Technician position at BioIVT?
Job Description
Job Description
SUMMARY
The Documentation Technician (Level 1) is responsible for the execution of the major tasks involved in the documentation process. These activities involve, ensuring that the Certificates of Analysis, Product Labels, X3 deliveries and FedEx air waybills are created efficiently and moved through the department expeditiously to ensure a seamless flow of orders from customer service through to the shipping and logistics team.
This position will ensure compliance with Environmental Health and Safety (EHS) policies, State Departments of Health, Good Documentation Practices (GDP), Good Laboratory Practice (GLP), Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), Good Laboratory Practice (GLP), Standard Operating Procedures (SOPs), EMEA and FDA Guidelines, general State and Country Regulations such as but not limited to (CLIA, CAP, USP, ISO 9001, USDA regulations, HTA license, DEA and State Controlled Substance programs) where site appropriate.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
- Work with Documentation Team Leader and other Documentation Technicians to support the Operations, Laboratory and Shipping teams.
- Prepare labels, FedEx Air Waybills and Certificates of Analysis for all orders shipping out of the Westbury site.
- Ensure that the daily flow of orders moves efficiently and prevent any delays in laboratory operations due to documentation delays.
- Provide direct communication to customers providing follow-up information on the status of viral pending material.
- Assist with general filing duties and off-site archiving process.
- Compile and transmit delivery notifications for all orders shipping out of the Westbury site.
- Support quality control checks for all outbound documentation and data.
QUALIFICATIONS
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and / or ability required.
Education and / or Experience
Certificates, Licenses, Registrations Required
Other Skills and Abilities
PHYSICAL DEMANDS
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions .
While performing the duties of this job, the employee may be required to : stand; walk, sit, stoop, kneel, crouch, crawl, speak, hear / listen, smell, display manual dexterity, reach with hand and arms. Specific vision abilities required by this job include close vision, color vision, depth perception, and ability to adjust focus. The employee must frequently lift and / or move up to 10 pounds and occasionally lift and / or move up to 30 pounds.
WORK ENVIRONMENT
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
This is a full-time Monday through Friday workweek with general business hours and flexibility to occasionally work additional hours as needed and approved by management. While performing the duties of this job, the employee will be working in professional office environment using standard office equipment.
The above job description is meant to describe the general nature and level of work being performed; it is not intended to be construed as an exhaustive list of all responsibilities, duties and skills required for the position. To perform this job successfully, the employee must possess the abilities or aptitudes to perform each duty proficiently. Employees will be required to follow any other job-related instructions and to perform other job-related duties requested by their supervisor in compliance with Federal and State Laws. All job requirements are subject to modification to reasonably accommodate individuals with disabilities. Continued employment remains on an at-will basis, unless otherwise contractually bound.
