Product Complaint Specialist

Highly Competitive Salary
  1. Permanent
  2. Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP)
  3. United States
North Chicago, USA
Posting date: 28 Oct 2020
QA.ZH.33864A

Proclinical is currently recruiting for a Product Complaint Specialist with a biopharmaceutical company located in North Chicago, IL.

Job Responsibilities:

  • Responsible for the receipt, processing, triage and quality assessment of all inbound safety information including adverse events and technical complaints for the company's marketed products (drugs and devices).
  • Ensure compliance with all internal and external (e.g. FDA) drug and device safety reporting requirements regarding the collection and maintenance of safety information.

Skills and Requirements:

  • A bachelor's degree required. Preferred degree in technology or scientific background (MLT, LPN, RN).
  • 0-3 years' work experience in a cGMP related industry or in a clinical setting is preferred.
  • 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.
  • 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.

If you are having difficulty in applying or if you have any questions, please contact Zachary Hines at 215-531-6914.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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