Document Change Control Analyst (ONSITE)

Please note that this is a 2-year contract position.

Description:

Top Three Skills:

• Documentation management and systems experience

• Computer proficiency

• Knowledge of FDA regulatory requirements for Biologics

Minimum Qualifications

• 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 with electronic document management systems (i.e. Veeva, MasterControl, 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

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

• Partner with other departments to ensure that documentation programs are completed in an efficient manner

• Perform 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:

  • Prepare and catalog documents for archival

  • Coordinate with internal and external groups for the archival of documents

  • Manage document retrieval from archive storage as requested

  • Regulate access to on-site document storage

  • Audit 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 in 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 inspection readiness 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

Applicants must provide their phone number. Reference job number A4915