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11 days old

Validation Coordinator

Kelly Services
Salt Lake City, UT 84190
Kelly Science & Clinical is excited to be hiring a **_Validation Coordinator_** (Direct Hire) for a leading medical device sterilization company in Salt Lake City, UT. The **_Validation Coordinator_** , as part of the Quality Assurance Team, will be responsible for ensuring the requirements for ISO and QSRs are met and maintained for the facility and its customers. The Validation Coordinator will also provide management with information and data on all key aspects of each validation project, which is used by both the plant and the customer to determine the course of routine processing.


**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 facilitys equipment and 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, 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


**EDUCATION, EXPERIENCE & SKILL REQUIRED:**


+ Minimum BA or BS in a science related field

+ 2-3 years of experience in the pharmaceutical, food or medical device industry in a quality or regulatory role.

+ Direct experience in sterility assurance or products sterilization a plus

+ Must have experience in writing and executing validation protocols

+ 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

+ Must be able to tolerate exposure to high temperatures and high humidity (120F and 60% RH for 20 minutes)


**_Interested Candidates:_**


+ **Apply for Immediate Consideration**

+ **Schedule and interview with Athena** https://calendly.com/athp320/interview


**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)

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Posted: 2021-06-07 Expires: 2021-07-08

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Validation Coordinator

Kelly Services
Salt Lake City, UT 84190

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