Document Control Specialist
1 week ago
At VIVEX BIOLOGICS INC, we are seeking a highly skilled Document Control Specialist to join our team. The successful candidate will be 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.
Key Responsibilities:
- Oversee and support Document Control staff to successfully operate and maintain the Document Management System (DMS) and related duties;
- Write and maintain DMS procedures and participate in the development, improvement, and roll-out of DMS tools;
- Develop and deliver training on DMS processes and roles;
- Manage the procedures and process for approval and release of labeling components.
- 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;
- Collect and report on metrics related to the state of the DMS;
- Collaborate with interdepartmental stakeholders during project development and execution as it relates to Document Management.
Requirements:
- 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 11/210/211/820/1271);
- Experience with electronic document management system 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.
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