Sr Validation Consultant
|March 28, 2018 - May 26, 2018|
|Location:||San Francisco, CA|
|Employment Type:||Full Time|
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.
The Senior Validation Consultant will perform the "full cycle" of validation services covering all validation documentation preparation, consulting with customers and delivering services remotely or on-site at the customer locations. The Senior Validation Consultant is responsible for ownership of customer validation and implementation issues that are addressed to him/her and is encouraged to use all legitimate resources available to solve problems.
|Duties:||ESSENTIAL DUTIES AND RESPONSIBILITIES:|
Deliver services to achieve complete validation of customers\' MasterControl Quality Application.
Provide customers with consultation services for development of validation and SOP documents.
Train customers in the application of validation principles and practices to the customer\'s application of MasterControl Quality Suite products.
Extensive technical writing testing protocols, procedures, and reports.
Communicate findings from fieldwork to product development team, e.g. functional requirements specifications, trace matrix, and validation IQ/OQ/PQ protocol testing enhancements.
Deliver \"go live\" readiness and maintain strong working relationships with customers.
Utilize approved validation document templates and presentations, resources, and tools.
Follow company policy for travel and expense reporting.
Other duties, as needed, e.g. support to Development in maintaining FRS and Trace Matrix documents.
PHYSICAL DEMANDS AND WORKING CONDITIONS:
Ability to communicate effectively in writing, in person, over the telephone and in e-mail
Ability to operate a computer and work at a desk for extended periods of time
Bending, stooping and lifting are aspects of this position when traveling to a customer site
Ability to work non-standard hours to accommodate travel to customer sites and work remotely within the customers business hours.
Ability to quickly learn technical skills
Up to 15% travel required.
B.S. Business/Science or equivalent experience, which is work experience on a software implementation project that includes full cycle validation (IQ, OQ, PQ)
GAMP Computer Systems Validation Training and experience required
Validation and Quality coursework and certification preferred; e.g. IVT, ISPE, PDA, PTi, ASQ
At least ten years\' experience in manufacturing industry; FDA-regulated industry experience preferred
Thorough understanding of a government-regulated manufacturing environment with capability to assess quality system deficiencies as well as conceptualize and document solutions
Excellent communication, organization, and interpersonal skills
Analytical and problem-solving skills
Proven success working in a dynamic, fast-paced team environment
Mastery of planning, coordination, and task prioritization skills
Experience working in both Waterfall and Agile methodologies is desired.
Why Work Here?
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!)
Employer Paid Life Insurance Policy ($50K)
Wellness Programs (every employee gets a Fitbit!)
Applicants must be currently authorized to work in the United states on a full-time basis.
For more information, or to apply now, you must go to the website below. Please DO NOT email your resume to us as we only accept applications through our website.
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