The Document Control Specialist is responsible for maintaining Southwest Transplant Alliance’s document control process to ensure integrity of documentation through its lifecycle from initiation to archive. The incumbent will ensure the document control process and documents are consistent with established standards. In addition, they are also responsible document control performance metrics.
Essential Job Functions:
Develop and maintain expertise in use of STA’s document management software.
Maintain user access to STA’s document management software.
Provide initial and ongoing training to staff on use of STA’s document management software.
As necessary, revise policies, work instructions and templates governing the document control process.
Assist document owners in editing all versions of controlled documents.
Assist document owners in ensuring controlled documents are compliant with applicable standards and regulations, are clear and concise and formatted appropriately.
Coordinate the review, revision, approval process within STA’s document management software, to ensure involvement of appropriate departments as well as appropriate representation from impacted personnel.
Coordinate the revision of related policies, procedures and forms to reflect initial chang Process, track and follow-up on all STA document change requests.
Work collaboratively with stakeholders to prioritize documentation deliverables based on needs and objectives.
Collaborate with Director of Education and Development to ensure appropriate training occurs prior to implementation of new and revised controlled documents.
Conduct final assessment of compliance of controlled documents with applicable standards and regulations and alignment with internal controlled documents.
Identify physical and electronic locations throughout the organization at which forms are stored for point of Cross-references forms with related/parent policy to ensure timely replacement of revised forms.
Establish pre-scheduled document implementation dates, providing for better organization of training, and aiding in timely reviews and approvals.
Ensure ongoing review of clinical policies and procedures as prescribed by regulatory agencies and accrediting bodies.
Maintain a formal system for sharing proposed document revisions, as appropriate, with members of the Governing and or Advisory Board.
Index and purge documents stored offsite in accordance with internal and external regulatory requirements.
Other duties as assigned.
Education and Work Experience Qualifications:
A Bachelor’s degree in physical sciences, quality studies, or a degree in another field with quality systems experience
Minimum two or more years of document control experience in regulated or certified industry is required.
Must have knowledge of commonly used concepts, practices, and procedures in healthcare.
Advanced proficiency in Microsoft Office and Adobe.
Demonstrated use of Q-Pulse is strongly preferred but not required.
Exceptional attention to detail.
Must demonstrate effective analytical, interpersonal, and time management skills.
Excellent communication skills require Must have the ability to communicate effectively with all levels of personnel.
Ability to work both independently and as part of a team required
Ability to cope with high levels of stress and able to handle a heavy workload.
Ability to meet assigned deadlines.
Internal Number: 1
About Southwest Transplant Alliance
STA’s purpose is to save lives through organ and tissue donation and transplantation. We can accomplish our mission when all employees believe in our core values of being passionate, selfless team players.
Our caring and compassionate staff offers hope to those facing the devastating loss of a loved one. Our team works in hospitals to guide grieving families through the organ and tissue donation process and to provide the clinical services needed to recover, prepare and transport organs and tissues for those awaiting a lifesaving transplant. STA is also committed to educating the public about the need for donation and the importance of donor registration by supporting the Donate Life Texas registry.