Description

Title: Quality Documentation Specialist

• Onsite 100% of the time in Wilson, NC
• Must have a Bachelor's degree
• Must have GxP Documentation experience
• The documentation is used published for trainings
• Must have experience with electronic document systems (Veeva Vault)
• Knowledge of life cycle of documents
• Quality Systems experience, the system itself and the documentation process
• Experience with CAPA, highly desired
• Pharma background, helpful
• Must have knowledge of FDA / EMEA regulatory documentation

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). T
• hese 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

• Receive and log documents submitted by site personnel for inclusion into the document control system
• Review received documents for conformance to site systems in respect of format, numbering, etc.
• Liaise with document owners in respect of approval schedules and implementation of new or revised documents
• Provide feedback from document review to the document owners

 Perform tasks related to administration of the Electronic Document Management System at the site.

• Add new users to the system and assign privileges as directed by the QA Systems Manager
• Set up review and approval routings for SOPs and other GMP regulated documents as directed by the QA Systems Manager
• Track documents through the review and approval processes and advise relevant personnel accordingly.
• Participate in upgrading activities of the system as appropriate.
• Generate reports from the system as directed by the Quality Systems Manager
• Develop and apply systems and procedures related to the Electronic Document management System at the site

Perform tasks related to the storage and archiving of documents related to BioNC including validation documents

• Prepares and catalogues documents for archival
• Coordinates with internal and external groups for the archival of documents
• Manages document retrieval from archive storage as requested.
• Regulates access to on-site document storage
• Audits internal and external document storage/archive systems

Minimum Qualification

• Bachelor’s degree in a scientific, engineering, or technical discipline is required
• minimum of 3 years of experience in document management or related role within the biological and/or pharmaceutical industry
• Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals and ability to apply GMP regulations and other FDA and international guidelines to all aspects of the position
• Excellent computer proficiency electronic document management system (i.e. Veeva, Master Control, Documentum, etc.)
• Excellent communication and interpersonal skills with the ability to effectively collaborate with cross-functional teams
• Proven ability to manage multiple priorities and work independently with minimal supervision