Documentation Technician I
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Job Summary
BioIVT is a leading global provider of research models and value-added research services for drug discovery and development. We specialize in control and disease-state biospecimens including human and animal tissues cell products blood and other biofluids. Our unmatched portfolio of clinical specimens directly supports precision medicine research aiming to improve patient outcomes by coupling comprehensive clinical data with donor samples. As the premier supplier of hepatic products including hepatocytes and subcellular fractions BioIVT enables scientists to better understand the pharmacokinetics and drug metabolism of newly discovered compounds and their effects on disease processes. By combining our technical expertise exceptional customer service and unparalleled access to biological specimens BioIVT serves the research community as a trusted partner in elevating science.
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.
Duties and Responsibilities
- 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 processesand 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.
Requirements
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.
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.
We offer a comprehensive benefit package for eligible team members including medical dental vision short-term/long-term disability life insurance hospital indemnity and accident insurance. We also provide a generous retirement plan with a company match. Eligible employees enjoy competitive time-off policies and a collaborative environment that promotes growth from within. Enjoy company-sponsored events for the entire team!
Join Us!
We cant wait to work with you! At BioIVT we believe that diversity and inclusion are key drivers of innovation and success. We are committed to creating a workplace where everyone feels valued respected and empowered to bring their unique perspectives to the table. We seek to build a diverse team and encourage applications from people of all backgrounds experiences and identities.
To Learn more about our mission and team culture click here!
BioIVT is an equal opportunity employer. We celebrate diversity and are dedicated to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity national origin disability status protected veteran status or any other characteristic protected by law.
Required Experience:
IC
Key Skills
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