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Quality Validation Specialist

Mastercontrol

Quality Validation Specialist

Salt Lake City, UT
Full Time
Paid
  • Responsibilities

    Quality Validation Specialist 28-Dec-2018 to 26-Feb-2019 (MST) Corporate Quality Salt Lake City, UT, USA Full Time ABOUT MASTERCONTROL MasterControl Inc. creates software solutions that enable life science and other regulated companies to deliver life-improving products to more people sooner. MasterControl's integrated solutions accelerate ROI and increase efficiencies by automating and securely managing critical business processes throughout the entire product lifecycle. More than 1,000 companies worldwide, ranging in size from five employees to tens of thousands, rely on MasterControl cloud solutions to automate processes for new product development, clinical, regulatory, quality management, supplier management, manufacturing and post-market surveillance. MasterControl solutions are well-known for being scalable, easy to implement, easy to validate and easy to use. For more information, visit . SUMMARY The Quality Validation Specialist is responsible for supporting the success of MasterControl's internal electronic Quality Management System (eQMS), which is comprised of, but not limited to customer feedback, document control, external audits, internal audits, improvement initiatives, quality events, management review, software validation, supplier management, and training. This position will also be responsible for sub-system administration duties with the MasterControl eQMS software and the review of MasterControl software validation documentation. MasterControl produces eQMS software for companies in the Life Sciences and other regulated industries. MasterControl uses its own software to administer its internal eQMS. The eQMS is audited frequently by clients, notified bodies (ISO), and regulatory entities (FDA). ESSENTIAL DUTIES & RESPONSIBILITIES Review and provide essential feedback on software validation documentation (but this is not a software tester position). #WeWantRegulatoryExpertsNotSoftwareTesters Oversee & act as sub-systems administrator for internal MasterControl production system. #WeLoveOurSoftware Initiate/revise, collaborate, approve, and route internal procedures Participate in facilitation of electronic employee training system Complete customer quality audit questionnaires #WeLoveOurCustomers Schedule and host on-site customer quality audits of MasterControl, Inc. Participate in internal & external audits Participate in local and cross-sectional improvement activities Other duties as assigned by management DESIRED SKILLS & EXPERIENCE Bachelor's Degree in Communication, Life Sciences, Regulatory Sciences (or equivalent degree or experience) is preferred Strong communication and writing skills are required. The ability to work with a team but be self-motivated is required. Integrity and accountability is required as the QMS is under constant scrutiny. Experienced with Microsoft Office Suite (Word, Excel, Outlook, etc.) is required. The ability to quickly learn new software applications is required. Experience with MasterControl QMS Software is preferred. Experience with Quality Management Systems (i.e. ISO 9001) is preferred. Minimum of 2 years experience in Life Science industry. PHYSICAL DEMANDS AND WORKING CONDITIONS Ability to operate a computer and work at a desk for extended periods of time Why Work Here? #WhyWorkAnywhereElse #ExceptionalTeamCulture MasterControl is a place where Exceptional Teams come together to do their best work. Hiring Exceptional Teams, including the best talent in our industry, is a core value of ours. MasterControl employees are surrounded by intelligent, motivated individuals every day. We like to call it #TheBestTeamOnThePlanet. We value every employee and their contribution to what makes MasterControl successful. We give right back to the employee through a generous benefits package, great flexibility, and continuous opportunities for advancement. Not only do we hire Exceptional Teams, but we work hard to keep them here by developing and challenging their skillsets, encouraging professional development and growth, and offering a culture that can't be found elsewhere. Which is why we say - #WhyWorkAnywhereElse? To put it simply, working at MasterControl is fun, challenging, and rewarding. From our Fitness Clubs to our awards programs, from our company parties to our competitive benefits, you can't really go wrong. MasterControl could be your next (and last) career move! We are growing quickly and always looking for talented individuals to add to #TheBestTeamOnThePlanet! Here are some of the benefits MasterControl employees enjoy: Generous PTO package of three weeks, increasing after just three years of employment Competitive compensation with annual merit increase reviews 100% medical premium coverage (yes, you read that right!) Dental/Vision Plans 401k Plan Employer Paid Life Insurance Policy ($50K) Great Flexibility Wellness Programs (every employee gets a Fitbit!) Applicants must be currently authorized to work in the United states on a full-time basis MasterControl https://mastercontrol.applicantpro.com

  • Industry
    Hospital and Health Care