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QA Documentation Specialist - I

San Dimas, CA 91773

Posted: 11/03/2022 Employment Type: Contract Job Category: Quality and Compliance Job Number: 513389 Country: United States Is job remote?: No

Job Description

Pay rate range: $22-28/hr
  • Processing documents following defined processes/procedures, scanning, filing, indexing of GxP related documents and records and coordination of off-site records
  • Analyze Change Requests for completeness. Communicates with customers to ensure changes are concise and complete
  • Ensures the correct and timely implementation of Change Requests (CR), Document Change Orders (DCOs) and Documents
  • Supports the distribution and maintenance of GxP documentation
  • Provides clerical and administrative support related to documentation and systems
  • Maintains documentation manuals to ensure accuracy and current information
  • Scans, verifies and archives documentation and records
  • Ensure the correct and timely input of database entries, verifies own work
  • May participate in training users for electronic systems (as applicable)
  • Understand and use document templates
  • Supports the maintenance of monthly document control metrics
  • Performs general word processing tasks and support. Checks format and conformance to document templates. Verifies own work.
  • Provides support for internal and regulatory audits/inspections as required
  • Provides additional support and assistance on tasks and projects as directed by management
  • Participates as required in training on issues affecting own are of work. Notifies manager of compliance questions and issues

Knowledge and Skills
  • Demonstrates working knowledge of Document Control fundamentals, Quality Systems and GMP requirements
  • Demonstrates basic understanding of the current pharmaceutical industry and applicable regulations including 21 CFR, GxP, ICH, etc
  • Demonstrates basic knowledge of Electronic Document Management Systems (EDMS)
  • Keeps abreast of the basic requirements for compliance in own work area
  • Demonstrates detail orientation and problem-solving skills
  • Demonstrates proficiency in Microsoft Office applications and Oracle environment
  • Demonstrates ability to work effectively in a team environment
  • Demonstrates strong verbal, written and interpersonal communication skills

Education and Experience
  • 5+ years of relevant experience in the pharmaceutical industry and a high school diploma
  • 3+ years of experience and AA degree
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