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1+ months

Quality Assurance (QA) Specialist II

Kelly Services
Waukegan, IL 60079
**Quality Assurance (QA) Specialist II-North Chicago, IL (3 positions)**



**Contract Length: 6 months W2**



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



**Pay rate: Up to $28.00/hour**



**_Candidates must have Product Quality Complaint experience and especially Device Complaint related experience._**



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



**Needed:** 1 year quality and/or complaint handling experience. Degree.



**Nice to have:** 3-5 years quality and/or complaint handling experience. Degree in science, nursing, or equivalent.



**Environment:** Cubicle environment, individual role



**Remote option:** Yes, we do have the option to work remotely. Currently it is not a set number of days but flexible


**Product Complaint Analyst I**


Individual will work in AbbVies global quality organization processing pharmaceutical, medical device and combination product complaints and inquiries. Interface with internal AbbVie 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 AbbVie 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!**



This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must submit your resumes. Thank you for your interest in the assignment.



**Also, feel free to follow up via email to RACS113@KELLYSERVICES.COM**






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



With Kelly, youll have access to some of the worlds highest regarded scientific organizationsproviding you with opportunities to work on todays most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits youll be proud to help advance. We work with 90 of the Fortune 100 companies and found opportunities for more than 10,000 scientific professionals last year.


You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your careerconnect with us today.




**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. 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. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm
Posted: 2019-12-18 Expires: 2020-01-25

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Quality Assurance (QA) Specialist II

Kelly Services
Waukegan, IL 60079

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