POSITION SUMMARY

The Document Control Administrator (DCA) is responsible for maintaining and managing the electronic document control system as part of the Quality Management System for The Donor Network. This position shall submit, track, and manage all documents through the system in a compliant, timely, and effective manner. The DCA also serves as an administrator for the electronic Quality Management System (QMS) platform, Q-Pulse.

ESSENTIAL FUNCTIONS

Essential Functions Statement(s):

• Responsible for understanding the inner workings and dynamics of the OPO electronic document control system and providing the required knowledge and skillset to administer the quality document control system for the organization.
• Receives and reviews document change requests. Responsible for determining whether the change request shall be approved for submission or rejected.
• Responsible for ensuring all new and revised documents have the correct control number, template, and properties set, ensuring consistency of documents and compliance with internal policies and procedures, performing spell check, and verifying that all reviewer comments have been addressed and those applicable incorporated within the document.
• Track draft documents within the electronic document control system to ensure all documents are being written, reviewed, and approved in a timely manner within the established timelines. Regularly run incomplete task reports in the electronic document control system and provide feedback from these reports to the document owners and appropriate management.
• Responsible for setting implementation dates within the electronic document control system for new or revised documents, ensuring sufficient time for staff training prior to implementation. Run necessary reports to ensure sufficient and applicable staff have read a new or revised document prior to implementation.
• Collaborates with the Training and Education Department leadership to ensure effective processes are in place for the document read acknowledgment training and other training as appropriate.
• Archive documents per the established the OPO’s quality document control system standard operating procedure.
• Develop and execute on-going training for all the OPO employees to ensure competent and efficient use of the document control and electronic database. Provide ongoing support to address all questions regarding the system.
• Develop and execute ongoing process improvement initiatives to streamline the document control System.
• Responsible for reviewing and revising the document control standard operating procedure to ensure it reflects current practice.
• Conduct the final assessment of compliance of controlled documents with applicable standards and regulations.
• Maintain a rolling 12-month cycle to ensure annual review of controlled documents as prescribed by regulatory agencies and accrediting bodies.
• Develop a formal system for sharing proposed controlled document revisions, as appropriate, with members of the Governing Board.
• Coordinate controlled document changes with the OPO's affected business partners, ensuring the OPO addresses processor requested changes as well as ensuring changes initiated by the OPO are, as appropriate, reviewed and approved by affected business partners prior to their implementation.
• Responsible for securing Medical Director approval and annual review for all applicable the OPO controlled documents per the established standard operating procedure.
• Actively monitor publications for all standards and regulations to ensure the OPO is referencing the most current version and is prepared for all pre-announced revisions. Communicate revision information to appropriate managers and directors.
• Provide the Regulatory Compliance Coordinator information on significantly altered processes for which internal audits may need to be performed.
• Manage the Planned Deviation process within the quality management software.
• Notify affected staff of issuance of a Planned Deviation
• Maintain appropriate documentation for Planned Deviations
• Track Planned Deviations to ensure timely incorporation into appropriate controlled document(s), if applicable
• Ensure timely closure of the planned deviations
• Responsible for assisting the QRA leadership as an Administrator of the electronic QMS platform, Q-Pulse. This includes, and is not limited to, creation of new and disabling of termed employee user accounts, security access settings, and workflow configurations.
• As needed, provide support to the QRA department with conducting audits in accordance to the OPO established standard operating procedures.
• Assist the QRA department with the facilitation of the storage and retrieval requests for offsite document storage.
• Other duties as assigned.
• Employees must adhere to and remain in full compliance with The Donor Network’s Motor Vehicle Driving Policy as outlined in the Motor Vehicle Records and Driver Safety policy PC.334.

POSITION QUALIFICATIONS

Competency Statement(s) – Position Specific

• Accuracy - Ability to perform work accurately and thoroughly.
• Active Listening - Ability to actively attend to, convey, and understand the comments and questions of others.
• Conflict Resolution - Ability to deal with others in an antagonistic situation.
• Customer Oriented - Ability to take care of the customers’ needs while following company procedures.
• Detail Oriented - Ability to pay attention to the minute details of a project or task.
• Honesty / Integrity - Ability to be truthful and be seen as credible in the workplace.
• Organized - Possessing the trait of being organized or following a systematic method of performing a task.
• Responsible - Ability to be held accountable or answerable for one’s conduct.
• Self-Confident - The trait of being comfortable in making decisions for oneself.
• Time Management - Ability to utilize the available time to organize and complete work within given deadlines.
  

Competency Statement(s) - Company Specific

• Understand and commit to the following:
• Organizational Core Purpose: To save and heal lives.
• Core Values: Relentless, Joyful, Selfless.
• Strategic Anchors: Mutually beneficial partnerships, diverse revenue streams, and get to yes: every donor every time
• Team Builder - Ability to convince a group of people to work toward a goal.
• Communication, Oral - Ability to communicate effectively with others using the spoken word.
• Communication, Written - Ability to communicate in writing clearly and concisely.
• Accountability - Ability to accept responsibility and account for his/her actions.
• Judgment - The ability to formulate a sound decision using the available information.
• Adaptability - Ability to adapt to change in the workplace.
• Diversity Oriented - Ability to work effectively with people regardless of their age, gender, race, ethnicity, religion, or job type.
• Compliance – Ability of the individual to be in accordance with established guidelines, policy, standards, or legislation.

SKILLS & ABILITIES

Education: Bachelor's degree in physical sciences or quality studies is required. Equivalent work experience may be substituted for education.
Experience: Four to six years of document control experience in regulated or certified industry.

Computer Skills: Proficient with Microsoft office suite.
Certificates & Licenses: None.
Other Requirements: None.

PHYSICAL DEMANDS

Physical Demands

Lift/Carry

Stand

O (Occasionally

10 lbs. or less

C (Constantly)

Walk

O (Occasionally

11-20 lbs.

O (Occasionally

Sit

F (Frequently)

21-50 lbs.

O (Occasionally

Handling / Fingering

C (Constantly)

51-100 lbs.

N (Not Applicable)

Reach Outward

O (Occasionally

Over 100 lbs.

N (Not Applicable)

Reach Above Shoulder

O (Occasionally)

Push/Pull

Climb

N (Not Applicable)

12 lbs. or less

C (Constantly)

Crawl

N (Not Applicable)

13-25 lbs.

O (Occasionally

Squat or Kneel

O (Occasionally)

26-40 lbs.

N (Not Applicable)

Bend

O (Occasionally)

41-100 lbs.

N (Not Applicable)

N (Not Applicable)

Activity is not applicable to this occupation.

O (Occasionally)

Occupation requires this activity up to 33% of the time (0 - 2.5+ hrs./day)

F (Frequently)

Occupation requires this activity from 33% - 66% of the time (2.5 - 5.5+ hrs./day)

C (Constantly)

Occupation requires this activity more than 66% of the time (5.5+ hrs./day)

Other Physical Requirements: Ability to wear Personal Protective Equipment (PPE).

WORK ENVIRONMENT: Non-smoking office.

The Donor Network has reviewed this job description to ensure that essential functions and basic duties have been included. It is intended to provide guidelines for job expectations and the employee's ability to perform the position described. It is not intended to be construed as an exhaustive list of all functions, responsibilities, skills and abilities. Additional functions and requirements may be assigned by supervisors as deemed appropriate. This document does not represent a contract of employment, and the OPO reserves the right to change this job description and/or assign tasks for the employee to perform, as the OPO may deem appropriate.