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Qualifications Education:

Bachelor's Degree required or 5+ years [LA3] [LC4] of experience in an FDA regulated industry;

Experience:

3+ years of experience in Document Control, Change Control, and/or Training, preferably in Tissue Banking, Biologics, Medical Devices or Pharmaceutical industry;
Strong knowledge of quality systems and regulatory requirements (21 CFR Part 11 / 210 / 211[LC5] [LA6] / 820);
Experience with document or learning 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 On-site. 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 Specialists, Change Control Coordinator, and Training Systems Coordinators 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. 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Find & Apply For Document Control / Management Specialist Jobs in North Miami, Florida

Quality Systems Manger