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Quality Assurance Manager

Kelly Services

Cleveland, OH
Job Code:
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Job Details

Job Title Quality Assurance Manager

Jobid US470jPG_BH1431367

Location: Cleveland, OH, 44101, USA

Description **Kelly Scientific is helping a great company to hire a top notch Quality Assurance Manager near Cleveland, OH.**

**Quality Assurance Manager** who is highly motivated with a quality assurance background and an interest in stem cell therapeutics to join our team. This position will report to the Sr. Director of Quality Assurance. In addition to documentation management, batch record and report review, primary responsibilities will be to:

+ Help administer document software for document control;
+ Help initiate, plan and drive the changes and processes that support building a company’s quality system;
+ Review records and release material and product for GMP;
+ Track QA metrics;
+ Assist with new employee training for GMP, GCP;
+ Write procedures, review, manage and write Deviations/CAPA/and OOS;
+ Facilitate project teams/meetings/change controls;
+ Perform or assist and support internal/external audits for compliance to GMP, GCP activities and assist managing supplier/vendor process;
+ Review and provide feedback comments on scientific/regulatory submissions;
+ Review and improve quality system documentation;
+ Write and/or review QA standard operating procedures to assess GMP, GCP compliance; and
+ Take part in projects and document reviews at all levels of the organization.
In addition, knowledge of, and direct experience with, Change Control, Employee Training, Vendor/Supplier Requirements/Regulatory Agencies or Audit is a plus.


+ Bachelor’s degree with 5-10 years QA experience (GMP, GLP, GCP);
+ Certified ASQ auditor preferred;
+ Demonstrated knowledge of regulated industries, such as: FDA, ISO, GMP, GTP, GCP;
+ Experience with implementation of corrective action programs;
+ Clinical trial experience would be very beneficial;
+ Strong interpersonal, leadership and communication skills;
+ Exceptional analytical and problem solving skills with great attention to detail;
+ Precise organizational skills and record-keeping practices;
+ Ability to multi-task in a fast paced environment;
+ Possess independent work skills with a strong work ethic and self-starter ability;
+ Capable of performing in a team setting; and
+ Willing and able to travel, as needed, less than 30% of the time.
**Why Kelly** **®** **?**

With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevantprojects. Our connections can lead you to innovative scientific pursuits you’ll be proud to helpadvance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 9,000scientific professionals last year.

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

**AboutKelly Services** **®**

As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit and connectwith us on Facebook , LinkedIn and Twitter .

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and iscommitted to employing a diverse workforce. Equal Employment Opportunityis The Law.

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