Document Control and Training Specialist 1

Document Control and Training Specialist 1

Requirements

• You understand general Document Control responsibilities and functions.
• You are able to perform each essential duty satisfactorily to perform this job successfully.
• You are proficient with Microsoft Office Suite.
• Your ability to create reports in support of other Quality Assurance systems is required.
• Your ability to use critical thinking and resolve issues will support department needs.
• Your knowledge of electronic documentation systems is a requirement.
• You have a good understanding of Document Control requirements and processes as outlined in ISO 13485 and 20 CFR part 820.
• You must have the ability to apply acquired knowledge of GDP and GMP to daily tasks.

Responsibilities

• You manage the change control system (Cloud PLM); review, problem solve, route, assess training impact and release change orders.
• You assist customers with problem solving and offer possible solutions utilizing understanding of the job and applies knowledge and skills to complete a wide range of tasks.
• You support the testing and improvement of the change control software and other supporting software.
• You assist in Cloud PLM software training and other training as required.
• You are responsible for management of department projects to ensure they are completed accurately and on time.
• You may support Quality in both external and internal audits.
• You support scanning, archival and retrieval of quality documents and records.
• You manage external standards in accordance with standard operating procedures.
• You generate and manage Quality Assurance reports as needed.
• Your position assumes and performs other duties as assigned.

Preferred Qualifications

• Typically requires 0- 2 years of related experience and a High school diploma/certificate or equivalent.