Quality Assurance Specialist

4 weeks ago


Chicago, Illinois, United States Collabera Full time

Collabera is seeking a skilled Quality Assurance Specialist to join our team. The ideal candidate will have a strong background in pharmaceutical quality control and a keen eye for detail.

  1. Assure complaint records meet global requirements.
  2. Product complaint documentation, investigation, and review of all non-medical complaint content.
  3. Responsible for reviewing Medical complaints that involve a non-medical quality related problem.
  4. Provide quality customer service through coordination of return samples for investigation and follow up activities such as replacement of product.

The successful candidate will have knowledge of global regulatory requirements for pharmaceutical, medical devices, and combination products. They will also have the ability to prioritize multiple projects to ensure compliance with regulations and standard operating procedures.

Key qualifications include:

  • Knowledge of global regulatory requirements for pharmaceutical, medical devices, and combination products.
  • Ability to prioritize multiple projects to ensure compliance with regulations and standard operating procedures.
  • Solid written/verbal communication and organizational skills.
  • Knowledge and application of computer systems for word processing and complaint management.
  • Ability to work with cross-functional teams and to interact effectively with peers, management, and customers.

A Bachelor Degree is required, with a preferred degree in technology or scientific background. 0-3 years' work experience in a cGMP related industry or in a clinical setting is preferred.



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