QA Specialist for Austin, Texas and North Chicago, Illinois

Responsibilities :

• Assure complaint records meet global requirements.
• Product complaint documentation, investigation, and review of all non-medical complaint content.
• Responsible for reviewing Medical complaints that involve a non-medical quality related event.
• Ensures that complaint documentation meets Good Documentation Practices as well as GMP and GCP. This requires good analytical skills, technical writing and good documentation. Responsible that complaint files meet all regulatory requirements.
• Identification of potentially reportable events and notification to appropriate functional groups and management.
• Provide quality customer service through coordination of return samples for investigation and follow up activities such as replacement of product, complaint categorization, and CAPA.
  

Qualifications:

• Knowledge of global regulatory requirements for pharmaceutical, medical devices and combination products.
• Knowledge of FDA requirements for Quality Systems, pharmaceutical products, and Medical Device
• Reporting regulations (21 CFR 803, 820 and 211) is preferred
• Ability to prioritize multiple projects to ensure compliance with regulations and standard operating procedures is preferred.
• A Bachelor's Degree required or 1-3 years of relevant work experience. Preferred degree in technology or scientific background (MLT, LPN, RN).
• 0-2 years’ work experience in a cGMP related industry or in a clinical setting is preferred

Pay Range:

$25/hr to $29/hr (Without any benefits)