Quality Assurance Specialist, Document Control

Under the direction of the QA Document Control Supervisor, the QA Specialist – Document Control, will control the movement, filing, archiving, and securing of all documents with the objective of ensuring compliance to company policies and procedures. In addition, the QA Specialist will review, issue, and reconcile controlled documents according procedures.

Maintain quality system controls to ensure state of complianceTake appropriate steps to reduce wastages and losses in the process and build improved efficiencyUnder guidance of the Senior QA SpecialistDocument Control, the QA Specialist - Document Control will:Respond to Document Control related activities throughout the siteIssue and reconcile controlled documents, process records for archival, retrieve documents as requestedFollow procedures as they relate to doc cell security and maintenancePerform document reviewPerform document implementation processes (Set Date)Execute activities within the Document Management Systems in a compliant mannerAssist in the implementation of all new electronic systems for document management.Other duties as requiredSupport all cross functional teams within the site for document control related needsSupport regulatory inspections and auditsMaintain documents per guidelines to ensure quick retrievalAssist in implementing systems to enhance document management process and daily operation.

Knowledge And Skills

Must be proactive, results oriented, with a strong attention to detail. Self-starter with good work ethic and ability to work independently with minimum supervision and use good judgment, or as a contributing member of a team. Ability to manage multiple projects simultaneously, meet deadlines, and handle an ever changing, fast paced critical work environment. Excellent verbal and written communication. Must be able to read, write, and speak English. Good computer skills with basic knowledge of Microsoft programs, particularly Outlook, Word, Excel, etc.

Knowledge of /or SAP (Systems, Applications & Products in Data Processing), MasterControl, Trackwise, is a plus.

Leadership / Managerial Attributes

Strong organizational, troubleshooting and problem-solving skills. Ability to analyze details and perform structured decision-making on a daily basis. Strong interpersonal skills with ability to interact with all levels of personnel in a professional manner.

Other Requirements (licenses, Certifications, Specialized Training)

Good communications skills GMP trainer a plus.