Document Control and Records Specialist

Position Summary

The Document Control & Records Specialist will support the Quality Team and will be responsible for daily activities related to document control, change management and archiving. In this role you will execute change management, store, manage, and track records, while ensuring the integrity, quality, and accuracy of all documentation. The Document Control and Records Specialist will collaborate across multiple departments to ensure timely completion of tasks and maintain adherence to requirements. 

Principal Responsibilities

The key areas of responsibilities are:

•    Execute an effective and efficient change management process in Global and Legacy Agile. 
•    Collaborate with teams to facilitate the timely implementation of change control processes. 
•    Maintains controlled documentation and records.
•    Maintains positive communication and collaborates with all levels at the site.
•    Responsible for accurate data entry and maintenance of records.
•    Ensure proper distribution and notification of document releases, revisions and obsolescence. 
•    Responsible for processsing changes.  
•    Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, company policies, operating procedures and processes.
•    Support internal and external audits as needed. 
•    Back up support for the traning function.  
•    Performs other related duties and responsibilities as assigned.
•    Support site goals and objectives.
•    Other duties as assigned. 

Education / Experience Requirements

•    High School diploma (Associates degree preferred)
•    2 years of experience in positions that require documentation, training and records retention environment. 
•    Strong computer skills including Microsoft Office 
•    Key competencies in verbal and written communication; attention to detail

Specialized Skills / Other Requirements

•    Computer skills, including proficiency with Microsoft Word, Excel, and PowerPoint is required.
•    Working knowledge and/or experience with SAP, AGILE and Veeva Vault strongly preferred.

•    Good listening, verbal, and written communication skills
•    Excellent interpersonal skills with a demonstrated ability to work in a team environment.
•    Ability to prioritize and adapt to shifting priorities.
•    Ability to work independently with limited supervision.
•    Exceptional attention to detail and strong organizational skills. 

TRAVEL REQUIRED: As needed for role and to support the business needs < 5% 

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