Specialist QA, Biopharma (JP4369)

Location: Woburn, Ma
Date Posted: 06-19-2018
Job Title:  Specialist QA, Biopharma (JP4369)
Location: Woburn, Massachusetts
Type: Contract
Duration: 12 months with possible extension
Business Unit:  ABV QA Plant Quality Assurance


3Key Consulting Inc. is looking for Specialist QA for a global, CA-based, bio-pharmaceutical company.
 
Description:
Responsible for providing Quality oversight to ensure that products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP) and other applicable regulations. Cross-functional quality responsibilities will
include investigation support, review of change controls, NC/CAPA/Change Control management, review of documentation, day-to-day quality support.

Responsibilities include:
• Review and Approval of Investigations, CAPAs, and Change Controls
• Audit and Inspection Support for quality processes
• Review and approval of documentation
• Support generation, review and approval of documentation
• Metrics reporting
• Own and drive to closure Investigations, CAPAs, and Change Controls
• Support training activities
• Support program alignment and integration into the Amgen Quality Systems
 
Top Must Have Skill Sets:
Min of 5 years previous experience in the below areas
  1. QA
  2. Investigations
  3. Compliance areas
  4. Training and quality systems
  5. Flexible to work with different quality processes and managing multiple priorities at the same time.
 
Day to Day Responsibilities:
  • Review and Approval of Investigations, CAPAs, and Change Controls
  • Audit and Inspection Support for quality processes
  • Review and approval of documentation
  • Support generation, review and approval of documentation
  • Metrics reporting
  • Own and drive to closure Investigations, CAPAs, and Change Controls
  • Support training activities
  • Support program alignment and integration into the Amgen Quality Systems
 
Employee Value Proposition: Provide exposure to quality management system support multiple quality areas from the technical perspective, perform execution as owner and in a quality role.
 
Red Flags: No Quality Assurance experience. Someone with just quality control experience will not be the right fit for this role.
 
Interview Process:  Could be a phone or person interview, or both
 
 
Regards,
 
3KC Talent Acquisition Team
 
 
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