Coordinator 2 - Document Control

Title: Quality Documentation Specialist

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

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

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

Partner with BioNC Learning & Development department in the provision of training in Good Documentation Practice (GDocP) and GMP to site personnel as directed by the Quality Systems Manager
Assist BioNC Learning & Development department the development and maintenance of training materials for provision of GDocP and GMP training to site personnel
Coordinate periodic review of all GMP documentation with site personnel
Manage the record retention program as it applies to global and local requirements
Support in inspection readiness at the as documentation and records management SME
Serve as a delegate for Quality Systems Manager when appropriate
Perform related duties as assigned by supervisor
Maintain compliance with all company policies and procedures

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
Detail-oriented mindset with a keen eye for identifying opportunities for process improvements
Ability to work in a team environment and interact with all levels of the organization
Ability to build and nurture strong and positive relationships
An unquestionable level of integrity and commitment to operate ethically and within the boundaries of regulatory requirements
Must be able to work independently with minimum supervision to meet tight deadlines and maintain a positive attitude.

Other requirements
Experience in development and/or evolution of GMP systems or start-up experience desired

Top Three Skills: Documentation management and systems experience Computer proficiency Knowledge of FDA regulatory requirements for Biologics