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1+ months

QA Specialist

Kelly Services
Alsip, IL 60803
Kelly Scientific is seeking a QA Specialist in Alsip, IL.


Temp to hire


Compensation: $25-$29/hour


Shift: Monday Friday 7:30am- 4:30pm


Lead the cross-functional management and execution of required activities within designated area(s) of the Quality Management System (QMS).


RESPONSIBILITIES:


+ Own the definition of QMS requirements and document these within the QMS documentation hierarchy, through knowledge and research of FDA QSR and cGMP regulations, and through partnership with global peers on related GC Global Guidelines.

+ Direct operations on the creation & revision of Quality Procedures to assure compliance with the related QMS requirements.

+ Drive the execution of daily management for related QMS processes, taking required action to investigate trouble reports and implement improvements.

+ Manage the assignment and verification of trouble reports to responsible associates based on issues occurring within related QMS process.

+ Own the management of Critical Quality Issues (aka CAPA), as assigned.

+ Manage the preparation of standard and ad hoc reports and KPI data for global reporting, as well as, perform analysis of trends and submit findings to superiors and global peers.

+ Prepare and submit data and related evidence for QMS Management Reviews.

+ Participate in external audits (ISO, FDA, etc) as a subject matter expert for related QMS processes, as needed.

+ Manage the response to audit non-conformities for related QMS processes, as needed.

+ Serve as Quality Management Representative in the absence of QA management.

+ Provide Quality Management System training to operations and other departments, as needed.

+ Participate in GQM improvement activities including high priority KI projects, as needed.


QUALIFICATIONS:


+ BA/BS Degree in science, engineering or related field is preferred.

+ 3+ years in a regulated life-sciences industry

+ 3+ years of related Quality Assurance experience. Quality certification (ASQ, etc.) is a plus.

+ Demonstrated understanding of Quality Management System requirements (ISO, FDA, etc)

+ Working knowledge and understanding in the use of QC tools & techniques (Control Charts, Histograms, Pareto diagrams, Cause & Effect diagrams, Process Flow Diagrams, Check sheets, Scatter Diagrams, etc.)

+ Strong communication, presentation, and influencing skills

+ Experienced technical report writing and analytical skills

+ Skilled in Microsoft 365 tools and technology


**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: 2021-03-12 Expires: 2021-04-26

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QA Specialist

Kelly Services
Alsip, IL 60803

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