Skip to content

Job Openings

QA Documentation Specialist - I

San Dimas, CA 91773

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

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
Apply Online

Send an email reminder to:

Share This Job:

Related Jobs:

Login to save this search and get notified of similar positions.

Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.

Wordpress Social Share Plugin powered by Ultimatelysocial