Documentation Specialist and ECO Analyst

Santa Clara CA US
Jun 07, 2016
Oct 26, 2016
Organization Type
Full Time
About Us:
PerkinElmer is a global technology leader driving growth and initiative in the Environmental and Human Health Science markets. The company is a leading force in the development, production, marketing, servicing, and supporting of laboratory instrumentation and ancillary services throughout the world.

We are seeking an Documentation Specialist and ECO Analyst based in Santa Clara, CA.

Position Overview:
Maintain organization of the company’s Document Control system to comply with Customer, QMS, ISO, FDA, and applicable regulatory / statutory requirements.

Specific Duties and Responsibilities
  • Sustain and improve site document control system by managing document control procedures and database.
  • Analyze, process and track engineering change order (ECO) submissions to minimize processing time between submission and implementation, optimizing department throughput.
  • Analyze ECO packages for complete information and insure proper authorization for release.
  • Process ECR / ECO packages from submission through implementation.
  • Interface with PKI CCC team members and customers for customer ECRs / ECOs. Communicate status
  • Maintain log / records of CCC meetings.
  • Assist PKI personnel with research of Customer part numbers, changes and BOM structures.
  • Initiate and chair the change control (CCB) board meeting.
  • Ensure that master drawing files, BOM, design history files, and design master records are accurate, current, and that effective control is maintained over drawings and other document records. (Protect Intellectual Property).
  • Maintain system for documents of external origin.
  • Maintain the ERP system for Item Masters, AVL and BOMs.
  • Super User for Document Control activities for the ERP system.
  • Support training activities for the ERP system.
  • Maintain system for documentation and records filing including off-site storage process and removal from use  archival of obsolete documents. Ensure that records are identified, legible, protected from deterioration / loss, are readily retrievable and retain for required duration.
  • Maintain system for Controlled Document Printing.
  • Support Internal and External Quality Audit/Inspections.
  • Facilitate the periodic review of documents.
  • Train personnel on document control processes and procedures.

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