Documentation Specialist

Job Description

Job Description

Title : Quality Documentation Specialist

Location : 5100 Corporate Parkway Wilson NC 27893

Duration : 2 years

Description :

Essential Job Duties and Responsibilities

This position is responsible for carrying out tasks and projects related to document control and document management for Wilson, NC (later referred to as BioNC) as required by current Good Manufacturing Practices (cGMP). These activities include the administration of the electronic document management system, preparation / submission of documents into and retrieval from archive, and the management of controlled documents through the review, approval, circulation and revision processes.

Specific tasks and job duties required include, at minimum :

• Provide support and direction to all departments in respect of document control to ensure business, quality and compliance goals are met
• Partners with other Departments to ensure that documentation programs are completed in an efficient manner
• Perform tasks related to tasks related to the management of document control and records management in respect of SOPs and other GMP regulated documents

i. Receive and log documents submitted by site personnel for inclusion into the document control system

ii. Review received documents for conformance to site systems in respect of format, numbering, etc.

iii. Liaise with document owners in respect of approval schedules and implementation of new or revised documents

iv. Provide feedback from document review to the document owners

i. Add new users to the system and assign privileges as directed by the QA Systems Manager

ii. Set up review and approval routings for SOPs and other GMP regulated documents as directed by the QA Systems Manager

iii. Track documents through the review and approval processes and advise relevant personnel accordingly.

iv. Participate in upgrading activities of the system as appropriate.

v. Generate reports from the system as directed by the Quality Systems Manager

Minimum Qualification

Other requirements

Top Three Skills :

Company Description

We believe in service that helps you solve a problem, move forward with a project, manage a difficult situation, or simply check something off your list.

Company Description

We believe in service that helps you solve a problem, move forward with a project, manage a difficult situation, or simply check something off your list.