Product Quality Complaint Analyst

Proclinical is currently recruiting for a Product Quality Complaint Analyst for a global biopharmaceutical company located in North Chicago, IL. Successful candidate will work in global quality organization processing pharmaceutical, medical device and combination product complaints and inquiries. Interface with internal customers such as physicians, nurses, pharmacists, hospital personnel, risk managers, purchasing agents, sales representatives, general public, manufacturing sites, technical support, commercial organization and PV regarding product complaints.

Job Responsibilities:

• Product complaint documentation, investigation, and review of all non-medical complaint content.
• Responsible for reviewing complaints that involve a non-medical quality related problem.
• Ensures that complaint documentation meets Good Documentation Practices as well as GMP and GLP. This requires good analytical skills, technical writing, and good documentation.
• Responsible that complaint data meet all regulatory requirements.
• Comfortable working with sharps (e.g. needles) that are potentially biohazardous.
• Identification of potentially reportable events and notification to appropriate functional groups and management.
• Interface with Third Party Manufacturers, internal customers, and internal functional areas.

Skills and Requirements:

• 1-3+ years' work experience in a cGMP related industry or in a clinical setting is preferred
• BA/BS required. Preferred degree in technology or scientific background
• Knowledge and application of computer systems for word processing and complaint management.
• Experience working in a testing lab environment preferred
• Solid written/verbal communication and organizational skills.
• Ability to work with cross-functional teams and to interact effectively with peers, management, and customers.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Nikki Ranieri at (+1) 215-531-5288 or upload your resume on our website - www.proclinical.com.

A full job description is available on request.

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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