Position Summary: The document control manager is an integral part of the Ossium Health Quality Management System (QMS). This position is responsible for control, security, accessibility, and timeliness of organizational documents such as policies, procedures, guidelines, forms, templates, and training materials.
- Help develop and enforce documentation design, review, and storage guidelines. Establish a complete and accurate index of company documents. Maintain paper and electronic files in the Quality document management system in accordance with Company policies and procedures, federal regulations, and accreditation requirements. Manage retention and archival schedule as well as off-site storage vendors as needed to archive and retrieve documents as necessary.
- Manage organizational documentation through the document life cycle, including document issuance, format review, routing for approval, scanning documents in electronic systems and maintaining hard copy as applicable. Ensure the security, accessibility, approval and proper distribution of organizational documents.
- Act as internal Subject Matter Expert on Document Control System. Provide training programs that encourage continuous improvement, personal development, and support accreditation and GXP regulations. Develop, maintain, and deliver training material in support of accreditation and GXP regulations.
- Support departments in collecting and maintaining files necessary to support the manufacturing process (i.e., SOPs, batch records, specifications, investigations, etc.), as well as facilitate the obsolescence, cataloguing and archival process.
- Work with IT to administer electronic systems and assign/approve user privileges.
- Support regulatory compliance and accreditation through generation and maintenance of required systems and documents.
- Develop, maintain and report metrics to support the continuous improvement of Quality Systems.
- A bachelor’s degree in biological sciences, physical sciences, information technology, or associated area of study is required. Experience using document management systems is required and experience in developing documents or managing content in document control system software is preferred. ASCP/MLS certification and clinical laboratory, blood bank or tissue bank experience are also highly preferred.
- The ability to communicate well with technical subject matter experts and document users is crucial.
- Good computer skills with basic knowledge of Microsoft programs, particularly Outlook, Word, Excel, etc. Knowledge of LIMS (Laboratory Information Management System), SAP (Systems, Applications & Products in Data Processing) and/or other electronic Quality Management Systems is a plus. The ability to work independently, or within a team structure, and on multiple projects, with flexibility to adapt to changing priorities is required.
Knowledge of FDA, CLIA, AATB, and AABB regulations and standards, and experience implementing new document control systems, 21CFR11 validations and technical writing experience preferred.