Document Control Specialist I

The Document Control Specialist I is responsible for maintaining the company's document control system in a regulated environment while also ensuring the accuracy, quality and integrity of the content. They will assure adherence to training, document reviews and record retention policies, safeguard information and retrieve data as needed.

Duties and responsibilities

• Perform word processing duties related to editing and writing policies, procedures, and other controlled documents.
• Review records to ensure compliance with applicable SOPs, agency requirements, accreditation standards, and regulations.
• Create job role specific training events based on the document control system.
• Initiate document revisions and route for approvals, when required.
• Assist the Document and Electronic Systems Supervisor in document control and training compliance within the Quality Management System (QMS) database.
• Identify and implement improvements to the document control system and maintain departmental databases.

Quality Assurance

• Maintain knowledge of and support VIVEX policies and procedures.
• Maintain knowledge of appropriate regulatory, statutory, accreditation requirements, and current Good Tissue Practices.
• Responsible for reporting all variances, errors, and deviations on all VIVEX initiated documentation to QA management. Participates in the investigation, implementation of corrective actions, and documentation of complaint files and nonconformance reports, as needed.
• Must gain knowledge of all regulations, laws, and/or standards that govern the tissue banking industry within first year in position
• Perform other duties as assigned by the manager.

Qualifications

Requirements for the Position:

• Associate degree
• Excellent interpersonal, verbal, and written communication skills
• Demonstrated excellence in organizational and record keeping skills
• Detail oriented, organized, accurate, ability to multi-task and solve problems
• Advanced computer skills in Microsoft platform

Preferred Candidate will also have:

• Bachelor’s Degree
• Knowledge of Good Manufacturing Practice and/or Good Tissue Practice regulations

Working conditions

Office oriented work environment. Some evening and weekend work may be required.

Physical requirements

While performing the duties of this job, the employee is regularly required to sit for prolonged periods of time. The employee may occasionally be required to pull, lift and/or move up to 20 pounds.

Direct reports

No direct reports

Nothing in this job description restricts management’s right to assign or reassign duties and

responsibilities to this job any time.

Vivex is an equal opportunity employer (EEO) and expressly prohibits any form of workplace discrimination and/or harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic information, disability, or veteran status. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, transfers, leaves of absence, compensation and training.

Vivex complies with the Americans with Disability Act (ADA) which prohibits discrimination against qualified individuals with disabilities who, with or without reasonable accommodation, can perform the essential functions of a job