The Quality Assurance Associate II performs documentation and review functions associated with manufacturing operations while ensuring compliance with cGMP regulations and Quality Systems.

Responsibilities

  • General QA GMP documentation activities to support Manufacturing Operations, as well as Quality Control, Facilities, Validation and Materials Management, that would include, but not be limited to:
  • Document formatting and review
  • Document attachment issuance, reconciliation and distribution
  • QUMAS EDMS document coordination
  • Maintenance, scanning and archiving of Quality Assurance documentation
  • Assignment of equipment numbers
  • Assignment of raw material and product part numbers
  • Label generation
  • Writing/revising SOPs and reports
  • Maintaining training documentation and electronic database
  • Maintaining Vendor/Material Change Notifications
  • SOP, Batch Record and Solution Record review
  • Internal auditing

Qualifications

Required Skills:

  • Broad knowledge of GMP quality systems, policies and regulations
  • Strong written and verbal communication skills
  • Proficiency using MS Office Suite (Word, Excel, Access)
  • Proficiency using an Electronic Document Management System (QUMAS or equivalent)

Education/Experience:

  • BA/BS with 3+ years GMP experience or AS/ABA/ABS with 5+ years GMP experience

 

Submit Resume

To apply for this job email your details to info@clinlabstaffing.com