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Document Control Specialist
Ref No.: 18-07020
Location: Sinking Spring, Pennsylvania
Position Type:Full Time/Contract
Start Date / End Date: 10/08/2018 to 10/08/2019
Alcon Precision Devices is a medical device manufacturer subject to global medical device regulations enforced by government agencies around the world. The Sr. Documentation Specialist position is responsible for performing the following tasks while adhering to site, corporate, regulatory, and industry policies and standards:
Administer item master files (parts list) in J.D. Edwards ensuring accuracy of data entry and compliance to department standard operating procedures and corporate and regulatory requirements
Collaborate with engineers to develop and/or revise bills of materials, routings, and associated device master record indexes.
Manage the revision of bills of material and coordinate with buyer/planners to minimize interruptions when new labels are introduced into production.
Process documents approved by APD’s DAR and Irvine’s ECN system according to department standard operating procedures.
Assign item numbers, document numbers, and document change numbers in the Documentation Database.
Maintain an organized system for retention and retrieval of controlled documents or quality records for routine business needs as well as availability for external agency review.
Perform binder audits and maintain the binder management system in the Documentation Database.
Manage controlled document lifecycle states and workflows in the Documentum Compliance Manager (DCM) system.
Assist document authors and editors in development of controlled documents and troubleshooting of document formatting issues
Assist in preparation for second and third party audits (ex: FDA, TUV, Corporate) and contribute as needed during inspection visits as related to the documentation control quality systems.
Manage assigned projects in a timely manner to meet commitments and deadlines.
Maintain quality service by enforcing quality and customer service standards; analyzing and resolving quality and customer service problems, identifying trends, and recommending system improvements.

Experience Required:
3-5 years of experience working in the Medical Device or Pharmaceutical industry (at least two of these year of experience must include change control and/or deviation investigations experience)
1-2 years of project management experience
Intermediate to advanced level experience with Microsoft Office and Adobe Acrobat software
Technical writing knowledge required.
Experience Preferred:
In addition to required experience, 1-2 years of direct experience in medical device audits.