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Quality Assurance Specialist - Pharma
Ref No.: 20-00488
Location: Summit, New Jersey
Job Description:
  • Maintains documentation filing systems for security, confidentiality and ease of use.
  • Files, tracks and/or retrieves archived information on a routine basis.
  • Maintains the archive system for off-site storage so that documents, records and files can be easily retrieved for audit and review purposes.
  • Conducts QA review of various types of files, records and batch records for completeness and accuracy according to SOP.
  • Notes and sets activities for all required follow-up. Follows-up to verify completion of activities.
  • Updates logs, databases and catalogs including, but not limited to, SOP Manuals, Training Records and SOP History Files.
  • Completes and provides data for Continuous Quality Improvement for all records reviewed per SOP.
  • Provides input/suggestions for revising standard operating procedures during annual review and process changes.
  • Coordinates the application and renewal processes for state and regulatory licenses, registrations and permits.
  • Reports non-conformances and/or quality related issues when observed.
  • Provides assistance to other QA staff members as needed.
  • Performs other QA duties as assigned.

Qualifications:
  • Basic scientific understanding.
  • Detail oriented with high degree of focus.
  • Able to follow instructions and procedures, both written and verbal.
  • Basic math skills.
  • Able to perform with minimal supervision and contribute in a team environment.
  • Able to communicate results and issues effectively, both written and orally.
  • Able to exercise judgment within defined procedures.
  • Basic knowledge and ability in using Microsoft Office Package.