Athenex Operations Document Control Specialist in Clarence, New York

Operations Document Control Specialist

Clarence, NY, United States Full Time

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POSITION OBJECTIVE: The Operations Document Control Specialist position participates in the overall control, maintenance and management of the documents that support pharmaceutical operations. This includes quality policies, processes, operating procedures, batch records and controls.

Essential Job Functions/Responsibilities

  • Prepare, update and manage controlled documents based on change controls initiated in the Engineering and Manufacturing organizations

  • Assess the impact of changes on associated documents and maintain revision history of documents affected by the change

  • Support Engineering in the creation and editing of production batch records

  • Build and maintain product structures in QAD (Routings and Bill of Materials)

  • Create and revise standard operating procedures and associated forms

  • Perform first pass batch record review

  • Perform backflush activities for consumed production materials in production management/finance system

  • Support label control in the creation of new label templates and routine label production

  • Manage a metrology schedule for the calibration and PV of production and laboratory equipment

  • Track and trend manufacturing and engineering KPIs such as schedule attainment and first time right

  • Other duties as assigned

Required Education & Qualifications

  • Minimum two (2) year technical degree or equivalent experience in pharmaceutical or medical device industry will also be considered

  • Minimum 2 year’ experience working with electronic & paper document control systems Experience working with MasterControl Document Management System is a plus.

  • Minimum 2 years’ experience providing administrative support

  • Experience with laboratory and manufacturing documentation is preferable.

  • Advanced computer skill using Microsoft – Word, Excel, PowerPoint and Visio; Adobe Acrobat

  • Ability to work effectively with people at all levels of the organization

  • Ability to work under time constraints with multiple projects and adapt to change

  • Strong attention to detail with each task

  • Self-driven and resourceful to achieve goals independently as well as work well in groups

  • Flexibility to adjust to changing requirements, schedules and priorities

  • Strong organizational skills and demonstrated attention to detail while managing multiple project and priorities