RAQA Technician

  • Location
    Waukegan , Illinois
  • Category
    Industrial & Manufacturing - Repair / Technician
  • Job type

RAQA Technician
Location: Waukegan, IL
Targeted Pay Rate: $20-25/hour
Estimated Duration (in months): 12 months
Total Weekly Hours: 40
Shift: 8-5pm Monday thru Friday

Description of Work:
Acquire and refresh P65 component data.
Update component files with supplier documentation/scanning of documentation
Assess standard kit P65 status impact for component P65 coding changes,
Assess standard kit P65 status impact for PCR code 5 and code 2 substitution requests,
Monitor WIP to ensure standard kits Bill of Materials are setup correctly to drive the P65 warning on labeling (thru January 2018),
Evaluate new standard kits for P65 status and recommend account configuration to drive regulatory coding and process controls,
Collaborate with Supply Chain and RSS Team to coordinate any duplicate CA standards or custom CA kits for setup,
Work with DQRA team to ensure that P65 standard kits have correct regulatory coding to restrict shipping,
Support process effectiveness check by participating in quarterly assessments of standard product lines account configuration.
Support qualification and FDA Regulatory data validation
Daily contact of suppliers to acquire and validate regulatory data compliance.

• Strong Microsoft office and excel skills proficient with query writing and use of macros.
• Strong written and verbal communication skills
• Ability to communicate within all levels of CAH regulatory organization including Sr leadership
• Back ground with UDI, preferred
• Medical product FDA regulatory background
• Registration of medical products with the FDA, highly preferred.

Disclaimer: Cardinal Health does not provide sponsorship for this opening. Candidates must now and in the future be legally eligible to work in the US for any employer.

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Reference number US_EN_2_022862_398570