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QA Validation Coordinator - Ontario, CA

Kelly Services

Ontario, CA
Job Code:
  • Engineering
Kelly Services
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Job Details

Job Title QA Validation Coordinator - Ontario, CA

Jobid US15TPKL_BH1420602

Location: Ontario, CA, 91758, USA

Description **QA Validation Coordinator, Ontario, CA**

**Job Summary:** Reporting to the Quality Assurance (QA) Manager, the Validation Coordinator acting as the facility technical representative is responsible for ensuring the requirements for ISO and QSRs are met and maintained for the facility and its customers. The Validation Coordinator provides management with information and data on all key aspects of each customer's validation project, which is used by both the plant and the customer to determine the course of routine processing. Must effectively interface with Sales, Operations, Corporate EO Technology, Engineering and other company's facilities, as well as customers and regulatory personnel.

**Job Duties and Responsibilities:**

+ Plans, organizes and coordinates customer validation activities at the facility
+ Writes validation protocols and final reports supplied by the facility
+ Reviews and approves customer or consultant supplied validation or test protocols for excitability within the limitation of the facility's equipment and company's operating procedures and compliance with current regulatory standards
+ Responsible for the execution of validation protocols and technically driven customer projects, which include but are not limited to the following:

+ Scheduling the project runs, ancillary resources, lab testing and sample handling

+ Cycle programming and preparation of necessary process documents and safety assessments

+ Microbiological samples

+ Data collection and analysis

+ Assuring proper handling, storage and shipping of bioburden, LAL biological indicators engineering, or residual samples to the appropriate laboratory
+ Assures that all validation calibration activities are performed according to QSR and traceable to NIST
+ Provides support to Maintenance or Engineering in the performance of IQ / OQ / PQ activities of new or existing facility equipment
+ Provides on-going training to the plant on validation issues
+ Maintains the quality and integrity of information required for validation records
+ Liaison for all plant and customer activities responding to customers' inquiries whether directly or through Quality Assurance (QA), Customer Service Unit or Sales, to ensure prompt and accurate communication related to technical and validation issues
+ Performs other duties as required to support the overall plant operation and quality system
**Job Requirements:**

+ Minimum BA or BS in a Science related field
+ Two (2) to three (3) years' experience in the pharmaceutical, food or medical device industry
+ Direct experience in sterility assurance or products sterilization a plus
+ Must have experience in writing and executing validation protocols
+ ISO 9000 experience a plus
+ Must be able to travel 20-25% of the time
+ Excellent written and verbal communication skills
+ Strong computer skills
**Special Requirements:**

+ Must possess a thorough understanding of US FDA Quality Systems Regulations and ISO 9000 regulations
+ Understanding of AAMI, EN and ISO guidelines for EO sterilization of medical devices is desirable
+ Knowledge and experience working with the US and International requirements for medical devices is essential
+ Knowledge of regulatory affairs for a FDA registered medical device or pharmaceutical manufacturer and direct experience with conducting or participating in FDA or supplier audits
+ Experience with a company using EO sterilization of products is desirable
+ Experience in document control to satisfy all ISO 9000 and FDA Quality System requirements
+ Must be medically approved for respirator use (EO)
+ Must be able to tolerate exposure to high temperatures and high humidity (120F and 60% RH for 20 minutes) (EO)
**APPLY TODAY! Questions? Call Kevin at 602-548-1774 or email at**

**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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