Job title: Document Control Coordinator
Location: South Tucson
Terms: Direct Placement
Salary/rate: $21.00 an hour
Requirements: No remote or hybrid, must be in office full time
GENERAL RESPONSIBILITES:
The Document Control Coordinator will be responsible for creating, maintaining, updating, and distributing documents as part of the Document Control Process. The Document Control Coordinator will also be responsible for review, filing, storage and maintenance of the Records Retention Process. The Documents Control Coordinator will have ownership over both Document Control and Records Retention processes and will ensure all applicable procedures are being maintained and followed by all Departments. This position will work closely with all other Departments on the development of new documents, updates to existing documents and ensuring compliance. The Document control coordinator will report to the Quality & Regulatory Manager.
SPECIFIC FUNCTIONS:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Provides guidance, training, and support for all Document Control & Record Retention functions for the site.
- Maintains all controlled documents and quality records per released processes and manages all associated logs and computer systems.
- Manages and coordinates the Document Control Process for the site by updating, assigning identification, routing, release, and distribution of all controlled documentation.
- Is responsible for the review, filing, storage and maintenance of the Records Retention process and final review of documents prior to filing.
- Ensures compliance with released Document Control Procedures, Record Retention Requirements, GMP/GDP, 13485:2016, and any other applicable standards for the site.
- Is the subject matter expert and go to for Document Control and Records Retention.
- Assists in coordinating, preparing, and participating in all required audits.
- Performs other duties as assigned.
- Associates degree desired, and/or equivalent industry certification. Will consider prior work experience in the appropriate fields.
- Knowledgeable of GMP/GDP, 13485:2016, 21CFR820 and any other applicable requirements.
- Experienced in document formatting, Word, Excel, Outlook, and PowerPoint.
- Previous audit experience desired.
- Excellent communication, interpersonal skills, attention to detail and is highly organized.