Document Management Associate
At SAB Biotherapeutics (SAB), we’re using the sophistication of science and genius of nature to change the landscape of human health. Our team of scientists, researchers and professionals has made it their life's work–with technology and tenacity–to pioneer a new powerful platform to make an impact that’s global + personal. Through advanced genetic engineering and antibody science, we are dedicated to advancing a new class of immunotherapies, leveraging the native human immune response, with first-in-class and best-in-class potential across broad therapeutic categories including autoimmune, inflammation, infectious disease and immune-oncology. SAB-185, is among the elite therapy candidates for COVID-19, advancing with Operation Warp Speed. As true innovation, our novel platform is also being developed in a rapid response capacity for future pandemic response.
The Document Management Associate is responsible for implementing and administering a company-wide document management system and related procedures for capturing, storing, retrieving, sharing, and destroying controlled records and documents. This position also includes management and oversight of documentation related to data entry, writing, editing, filing and archiving of controlled documents, completed records and archived samples generated from 21CFR part 58 Good Laboratory Practice (GLP) Nonclinical Laboratory Studies.
Responsibilities include, but are not limited to:
- Ensure that organizational documents, including Standard Operating Procedures (SOP), protocols, and other miscellaneous documents, go through a documented and approved review/approval process before being implemented.
- Scan, image, organize, maintain and archive paper and electronic documents and records.
- Retrieve documents from storage for distribution to users, collecting and returning to storage, if necessary.
- Maintain a state of document inspection readiness for regulatory inspections and client audits.
- Ensure the security, accessibility, and proper distribution of organizational documents.
- Help develop and enforce documentation design, review, and storage guidelines.
- Responsible for training employees on records management procedures and policies, which include documentation, retention, retrieval, destruction and disaster recovery.
- Assist with file migrations and audits.
- Utilize SAB’s computerized systems to perform document control and training responsibilities.
- Responsible for maintaining personnel training plans and distributing controlled documents to employees for training.
- Issue manufacturing batch records, laboratory notebooks, and equipment logbooks for use in production and laboratory activities.
- Assist in the assessment, acquisition, and/or deployment of new electronic document management systems.
- Monitor regulatory activities to maintain compliance with records and document management laws.
- Work with IT to assign user privileges.
- Able to perform tasks with minimal error.
- The individual must be self-directed, have the ability to work independently, manage time well and be highly-motivated; attention to detail is crucial.
- To perform this job successfully, an individual should have experience with filing, scanning and organizing documents.
- Must be proficient in Microsoft Office software (Word, Excel, PowerPoint and Outlook) and Adobe Acrobat.
Education, Experience and Certifications:
- Associate or Bachelor degree.
- 3 years of related experience in document management preferred.
Must have strong interpersonal communication skills. Ability to effectively present information in one-on-one, small groups and lab meetings.
Utilizes established mathematical and scientific techniques to compile and analyze data.
While performing the duties of this job, the employee is regularly required to walk, stand and sit. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision, peripheral vision, and the ability to adjust focus.
Normal office environment with some exposure to lab areas. The noise level in the working environment is usually moderate.
The employer will make reasonable accommodations in compliance with the Americans with Disabilities Act of 1990.