Kelly Services Quality Assurance Specialist in Lake Zurich, Illinois
Kelly Services is currently seeking a Quality Assurance Specialist in Lake Zurich, IL to work a contract assignment of 16 weeks for one of our top clients. Kelly is a full service workforce solutions provider to 98% of the Fortune 100™ companies. We provide employment to more than 700,000 people annually and we deal with some of the largest and best companies both nationally and locally.
Primary Responsibilities of the Quality Assurance Specialist includes:
The Quality Assurance Specialist functions as a regional role supporting all Fresenius Kabi sites within North America (NAM) ensuring all QA data and reports subject to FDA inspection are in alignment with SOP and cGMP requirements. In this capacity, the QA Specialist is responsible for the processing of electronic Change Notices using the Documentum Electronic Document Management System (EDMS) and paper-based Document Change Notices (DCNs) and preparing metrics that report on the compliance of cGMP documentation. The QA Specialist also assists department Material Part Number assignment for Finished Products to ensure accurate, consistent, compliant and efficient maintenance of records. The QA Specialist role interfaces with the departments of Innovation & Development, Regulatory Affairs, Contract Manufacturing, Packaging Development and Sales & Marketing to ensure accurate approval of documentation and in support of new Product Launches.
PRINCIPAL ACTIVITIES PERFORMED BY THE INCUMBENT
Verifies compliance of all cGMP documents and data processed including, but not limited to, the document types of electronic Change Notices, paper-based Document Change Notices, Policies, SOPs, Specifications, Methods of Analysis and Protocols.
Coordinates and issues Document Change Notices (DCNs) associated with GO NAM sites, Packaging & Development, Regulatory Affairs, Contract Manufacturing, Innovation & Development and Sales & Marketing.
Ensures on-time review and approval processing of cGMP documents.
Generates and distributes monthly metrics reporting on the status of Change Notices routing for review and approval.
Performs weekly follow up of Change Notices to ensure processing towards completion.
Generates and distributes monthly metrics reporting on the status of 36-month document reviews of Policies and SOPs to facilitate compliant processing.
Distributes timely notifications to NAM locations on the publication of Global Quality Management documents.
Administers NAM procedure compliance assessments on the publication of Global Quality Management documents to ensure assessments evaluate global processes against local processes.
Serves as back-up Documentation Coordinator to the Regional GO NAM.
Maintains documentation archives to ensure documents are orderly, complete, accurate and readily available for inspection.
Ã¢ Education and Experience Requirement of the Quality Assurance Specialist includes :
Bachelor of Science/Bachelor of Arts degree or equivalent work experience required, with a minimum of 3 years of QA experience in the pharmaceutical or related industry.
Working knowledge of GMPs and related Quality System processes is required.
Experience with Documentum Electronic Document Management System (EDMS) is required.
Quality Management module.
Position requires individual with high degree of accuracy. Must be able to translate theoretical knowledge into practical application.
Good oral communicational and interpersonal skills is required.
Good organizational skills is required.
Previous pharmaceutical industry experience is desirable (QC/QA/Regulatory).
Working knowledge of automated record keeping/retrieval systems is desirable.
Working knowledge in the software applications of Microsoft Excel and Microsoft Word.
Contract assignment, duration 16 weeks.
Work schedule: full-time, first shift; 7:00 am -3:30 pm or 7:30 am – 4:00 pm
Kelly Temporary Employee Perks:
Group medical, prescription, vision, dental, life, and short-term disability insurance options that are available for purchase—and the coverage is portable*
Service bonus plan and Holiday pay plan, if qualified
Weekly electronic pay options
Free online training campus available
Exclusive online employee community
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 resume to the Scientific Recruiter listed below:
Please email your resume directly to Sandy at: Sanm174@KellyServices.com [reference BH Job #3075502]
Thank you for your interest in the assignment.
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 interests—it’s 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, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/non-traditional 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 and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.