Documentation Technician

SUMMARY

This position will be responsible for efficiently and accurately completing documentation at the facility.

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 based on-site requirements. Other duties may be assigned.

• Follow Standard Operating Procedures (SOP), IRB Protocols, and regulatory

requirements.

• Complete all process and procedure training as required.
• Ensure air bills, packing slips, manifests, and certificates of analysis are produced accurately and efficiently utilizing approved templates.
• Organize, categorize, and store physical and digital documentation.
• Perform regular audits of documents to ensure accuracy and completeness.
• Ensure that documents are legible, properly formatted, and in accordance with established guidelines.
• Work closely with the operations team on strategic initiatives and provide input on how to improve documentation processes and procedures.
• Perform shipping notifications to customers ensuring all relevant information is provided.
• Assist in the creation of product labels according to specifications, as necessary.
• Support quality control checks for all documentation and data.
• Communicate with customer service any sales order issues, including production issues and documentation issues to ensure proper customer communication.
• Continually improve communication process between different areas to reduce errors and increase efficiencies.

TRAVEL

This position may require up to 2 % travel over the course of a year.

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

• High School Diploma or equivalent, required.

Certificates, Licenses, Registrations Required

• None required.

Certificates, Licenses, Registrations Preferred

• None required.

Other Skills and Abilities

• Proficiency in a variety of computer software programs including MS Office
• Ability to work in a team laboratory environment with knowledge or familiarity with scientific terminology.
• Ability to communicate clearly with colleagues, management, and suppliers.
• Ability to work under pressure.

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, and stoop.

The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 30 pounds.

WORK ENVIRONMENT

General business hours for the position will be Monday - Friday. Occasionally evening hours and weekends may be required. While performing the duties of this job, frequently required to use personal protective equipment to prevent exposure to hazardous materials. The employee has potential for exposure to fumes, airborne particles and toxic or caustic chemicals, biohazards, flammable liquids. The employee is occasionally required to use equipment with moving mechanical parts, with risk of electrical shock and vibration. The noise level in the work environment is usually moderate, at times, the noise level can be louder and hearing protection may be required. The employee may work both inside and outside in heat/cold, wet/humid, and dry/arid conditions.

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.