Quality Assurance Associate

Job Description

Provides Administrative support by

• assisting with routine quality assurance activities
• performing administrative functions within the QA group
• supporting Quality-related Help Desk and e-mail requests
• assisting in Analytical Subcontractor documentation maintenance
  
  

Supports Data Reporting By

• reviewing, approving, and releasing laboratory data
• assisting with review and approval of Certificates of Analysis and Cumulative Reports
• assisting with review and verification of Technical Reports and Summaries
  
  

Assists In Document Control By

• issuing Master Lists numbers
• issuing Laboratory Notebooks and Logbooks
• issuing and maintaining Controlled Copies
• maintaining the Technical Library
• maintaining Archival of Records
  
  

Supports Stability activities as assigned

Supports Manufacturing Activities As Needed By

• executing the quality assurance roles of batch records
  
  

Other duties as assigned

Qualifications

Required: a minimum of High School Diploma or Equivalent. Preferred Bachelor’s Degree and/or certifications in laboratory/quality/regulatory

Required: Understanding of FDA requirements and Quality Systems

Preferred: Must have good administrative skills (Microsoft Office Suite, LIMS, QMS)

Preferred: 1 – 2 Years in a laboratory environment.

Preferred: 3 years of GLP/GMP environment in laboratory operations or QA, or combination of both

Additional Information

Position is full-time, Monday - Friday 8:00am - 5:00pm . Candidates currently living within a commutable distance of Cary, NC are encouraged to apply.

• Excellent full time benefits including comprehensive medical coverage, dental, and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays
  
  

**Eurofins USA BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.**