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6 days old

Product Complaint Analyst

Kelly Services
Waukegan, IL 60079
**Product Complaint Analyst**


**Job Description:**


+ Product Complaint Analyst I Individual will work in Clients global quality organization processing pharmaceutical, medical device and combination product complaints and inquiries.

+ Interface with internal Client 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 Clients product complaints.

+ Responsible for product complaint documentation, investigations and identification of potential adverse events and potentially reportable events.

+ Responsibilities may include creation and submission of regulatory reports, creation of customer communications and interface with various third parties.

+ 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 problem.

+ Provide quality customer service through coordination of return samples for investigation and follow up activities such as replacement of product.

+ 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. Interface with Third Party Manufacturers, health care professionals, general public, internal customers, AbbVie functional areas and regulatory agencies.


**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.

+ 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 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


**Apply Now!**


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)
Posted: 2021-06-11 Expires: 2021-07-12

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Product Complaint Analyst

Kelly Services
Waukegan, IL 60079

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