MasterControl
  • 03-Jan-2019 to 04-Mar-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 www.mastercontrol.com.

SUMMARY

The Quality Audit Specialist is responsible for supporting the success of MasterControl's audit program. The Quality Audit Specialist performs internal audits, conducts supplier audits, and hosts weekly customer audits at MasterControl Headquarters. Auditing is performed against applicable ISO and FDA standards and regulations.

In addition to carrying out the duties of the audit program, the Quality Audit Specialist is responsible for the sub-system administration duties within the MasterControl electronic Quality Management System software, as well as performing reviews of software validation documentation.

RESPONSIBILITIES

  • Schedule and host weekly on-site customer quality audits
  • Carry out quarterly internal audit activities
  • Review and audit suppliers as part of the Supplier Management process
  • Complete customer quality audit questionnaires
  • Review and provide essential feedback on software validation documentation
  • Oversee & act as sub-system administrator for internal MasterControl documentation system
  • Initiate/revise, collaborate, approve, and route internal procedures
  • Facilitation and oversight of the electronic employee training system
  • Participate in local and cross-sectional improvement activities
  • Other duties as assigned by management

SKILLS

  • Minimum of 2 years' work experience in a Life Science industry required
  • Experience with Quality Management Systems (i.e. ISO 9001, ISO 13485, etc.) required
  • Experience with FDA regulations (i.e. 21 CFR Part 11, 21 CFR Part 820, etc.) required
  • Previous audit experience (supplier, internal, hosting, etc.) required
  • Strong communication and writing skills required
  • The ability to work well in both a team and individual work environment
  • Integrity and accountability is required as the QMS is under constant scrutiny
  • Experience with Microsoft Office Suite (Word, Excel, Outlook, etc.)
  • The ability to quickly learn new software applications as required
  • Experience with MasterControl QMS Software is preferred

PHYSICAL DEMANDS AND WORKING CONDITIONS

  • Ability to operate a computer and work at a desk for an extended period of time
  • Ability to travel and attend events where one may be standing for long 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.

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