Job purpose
Directly responsible for managing the daily operations of the document control and training system processes and procedures. Implements and directs documentation procedures in storage, revision, retrieval, and release of records. Assist departments in developing training processes to standardize organizational training and documentation. Serve as a resource for the development and advancement of training programs offered to our employees and customers.
Duties and responsibilities
1. Oversee and support Document Control & Training staff for program success and compliance;
2. Manage document and training operating procedures and databases.
3. Manage the approval and release of labeling components.
4. Participate in the development, improvement, and roll-out of DMS and training tools;
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 and Training System;
7. Collaborate with interdepartmental stakeholders during project development and execution as it relates to Document and Training Program Management.
8. Assist employees with registration and preparation activities for the Certified Tissue Banking Specialist exam.
9. Other functions and responsibilities as assigned.
Quality Assurance
1. Maintain knowledge of and support company policies and procedures;
2. Maintain knowledge of appropriate regulatory, statutory, accreditation requirements, and current Good Tissue Practices (cGTP);
3. Support site inspections by FDA, AATB, State, and other Third Party Agencies;
4. Responsible for reporting 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.
Qualifications
Education: · Bachelor’s Degree required or 5+ years of experience in an FDA regulated industry;
Experience: · 3+ years of experience in Document Control and/or Training, preferably in Tissue Banking, Biologics, Medical Devices or Pharmaceutical industry;
Skills:
Strong knowledge of quality systems and regulatory requirements (21 CFR Part 11 / 210 / 211 / 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;