21 days old

Product Complaint Analyst I _Waukegan, IL

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

Kelly Services is currently seeking a Product Complaint Analyst I for one of our top clients in North Chicago, IL.

Pay: $28/hr - $32/hr

Duration: 6 mon (potential of being extended)

Hours: M-F 8-4:30/5

Individual will work in the companys global quality organization processing pharmaceutical, medical device and combination product complaints and inquiries. Interface with internal the companys 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. 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.


+ 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, companys functional areas and regulatory agencies.

**Qualifications** :

+ Knowledge of global regulatory requirements for pharmaceutical, medical devices and combination products.

+ Candidates with Product Quality Complaint experience preferred and especially Device Complaint related experience.

+ 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

**Additional Information from Manager:**

What are the top 5 skills/requirements this person is required have?

Required Skill 1: Detail oriented

Required Skill 2: Microsoft Excel Knowledge and Experience Pivot tables, sorting, filtering are a must

Required Skill 3: Adaptive to change

Required Skill 4: Self-starter/independent worker

Required Skill 5: Taking initiative to improve/create efficiency

+ What years of experience, education, and/or certification is required? 1-year quality and/or complaint handling experience. Degree.

+ What is a nice to have (but not required) regarding skills, requirements, experience, education, or certification? 3-5 years quality and/or complaint handling experience. Degree in science, nursing, or equivalent.

+ What is the environment that this person will be working in (i.e. group setting vs individual role)? Cubicle environment, individual role

+ Is any testing required for this role? None

+ Does this position offer the ability to work remotely on a regular basis or is it an on-site role? If remote opportunity exists, what are the options (i.e. 1 day remote, 4 days on-site)? Yes, we do have the option to work remotely. Currently it is not a set number of days but flexible

+ Currently with COVID-19, majority of the team is working remote. As guidelines are changing, normal business guidelines are working on-site 3 days a week with a possibility to works up to 2 days remote.

+ Other notable details from the hiring manager about this role this role requires sitting at a computer for long periods of time, candidate must be comfortable in that type of environment

+ This role requires sitting at a computer for 8 hours a day.

Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. Applicants must be legally permitted to work in the United States. Email for questions about the position but please apply online to be considered for the position.

Why Kelly?

+ As a Kelly Services employee, you will have access to numerous perks, including:

+ Exposure to a variety of career opportunities as a result of our expansive network of client companies

+ Career guides, information and tools to help you successfully position yourself throughout every stage of your career

+ Access to more than 3,000 online training courses through our Kelly Learning Center

+ Weekly pay and service bonus plans

+ Group-rate insurance options available immediately upon hire*

Apply Today!

*Available for purchase and administered by a designated third-party vendor

**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. (
Posted: 2021-04-02 Expires: 2021-05-03

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Product Complaint Analyst I _Waukegan, IL

Kelly Services
Waukegan, IL 60079

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