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Documentation Associate

Job Post Index 213F22-Sy##
Location Morris Plaines, NJ
Description: Description
  • Maintenance of record life cycle management within the document control archive in a compliant and secure manner per cGMP regulatory requirements and in accordance with the Quality Manual.
  • Maintain and follow procedures for issuance, receipt, reconciliation, filing, and archives on-site and/or off-site.
  • Issue document numbers/templates, reconcile, file, and archive technical protocols/reports, validation protocols/reports.
  • Provide execution copies as needed
  • Enter/maintain information accurately following GDocP to support operations and overall life cycle of documents and records.
  • Taking inventory and ordering of supplies for the Documentation and Issuance team
  • Complete job-related training in electronic database system along with GMP, safety, and Ethics and Compliance course requirements.
Skills: Qualifications
  • Knowledge with manufacturing quality (manufacturing, packaging, facilities, critical systems, automation, validation, etc.) preferred.
  • Experience in Quality Assurance, CAPA, Change Control, Document Control, and Training Systems.
  • Continuous improvement mind set.
  • Ability to communicate clearly (written and verbal) and in an engaging manner with colleagues of various levels of experience and management.
  • Comfortable working in a team environment and communicating with site and possible other global positions.
  • Sciences, chemistry, pharmacy, engineering or equivalent education/experience in Pharmaceuticals.

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