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Document Control

3 months ago

Miami, United States VIVEX BIOLOGICS INC Full time
Job DescriptionJob DescriptionDescription:

Job purpose

Directly responsible for managing the daily operations of the document and record control processes, policies, and procedures for the secure management and access of company information assets. Implements and directs documentation procedures in storage, revision, retrieval, and release of records. Administrator for the electronic Document Management System (DMS).


Duties and responsibilities

Document Control

  1. Oversee and support Document Control staff to successfully operate and maintain the Document Management System (DMS) and related duties;
  2. Write and maintain DMS procedures and participate in the development, improvement, and roll-out of DMS tools;
  3. Develop and deliver training on DMS processes and roles;
  4. Manage the procedures and process for approval and release of labeling components.
  5. Execute and enforce security protocols for the access, storage, backup, maintenance, reproduction, protection, and disposition of all documents to comply with AATB, FDA, and state regulations;
  6. Collect and report on metrics related to the state of the DMS[LA1] [LC2] ;
  7. Collaborate with interdepartmental stakeholders during project development and execution as it relates to Document Management.
  8. Other functions and responsibilities as assigned.

Quality Assurance

  1. Maintain knowledge of and support Vivex Biologics, Inc. (Vivex) policies and procedures;
  2. Maintain knowledge of appropriate regulatory, statutory, accreditation requirements, and current Good Tissue Practices (cGTP);
  3. Support site inspections by the FDA and other Third Party Agencies;
  4. Responsible to report all variances, errors, and deviations on all Vivex initiated documentation according to procedure.
  5. Participate in the investigation, implementation of corrective actions, and documentation of complaint files and nonconformance reports, as needed;
  6. Perform other duties as assigned.
Requirements:

Experience:


· 3+ years of experience in Document Control, preferably in Tissue Banking, Biologics, Medical Devices or Pharmaceutical industry;

· Strong knowledge of quality systems and regulatory requirements (21 CFR Part 11/210/211[LC1] [LA2] /820/1271);

· Experience with electronic document management system preferred.

Skills:


· Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment as a leader;

· Ability to work on multiple assignments in collaboration with other departments with the successful completion of projects;

· Strong organizational skills and attention to detail a must;

· Excellent technical writing and editing skills;

· Advanced computer and word processing skills with MS Word;

· Strong working knowledge of Microsoft Excel, PowerPoint, Visio;

· Experience with Adobe Acrobat, Adobe Sign, SharePoint preferred;

Licenses/

Certifications:


CTBS or ASQ certification preferred.


Working conditions

Primarily a quiet office work environment. Some evening and weekend work may be required. Facility temperatures are maintained cool.


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

Document Control Specialist


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.