Sr. Quality Systems Business Analyst

City
US - Nationwide

Job Type
Full-Time Regular

Job Description

Bull City Talent Group is seeking Organizational Change Management professionals for a full-time position with our client Clarkston Consulting. This position is a road warrior traveling consultant so your home base can be anywhere near a major airport. Eligible candidates must be a US Citizen or Green Card Holder.

Clarkston Consulting provides management and technology consulting services for companies in the consumer products and life sciences industries with a 95% client satisfaction rating.

Sr. Quality Systems Business Analyst - Job Description


Clarkston gives you the opportunity to deliver great solutions, become recognized as an industry expert, and help build a great practice. As Sr. Quality Systems Business Analyst at Clarkston you will:

  • Work directly with clients at all different levels to guide complex projects and develop innovative solutions
  • Focus on business process re-engineering efforts and FDA compliance process design
  • Earn trusted client status and build relationships that extend beyond the project’s lifecycle
  • Apply strong knowledge of the Life Sciences industry for conducting root cause analysis to help redesign and implement improved site-wide Quality Processes and Systems, including but not limited to deviation management, CAPA management, risk processing, and change control for our clients.
  • Conduct knowledge transfer and training of end-users, including sharing best practices
  • Provide leadership to junior systems analysts and client personnel assigned to projects

Qualifications

  • Bachelor’s degree in Business, Computer Science, Math, Engineering, or equivalent discipline required
  • A minimum of five (5) years relevant professional consulting experience in the Life Sciences industry, with advanced knowledge of electronic records requirements/compliance protocols (cGMP, GMP, FDA regulations, 21 CFR Part 11, 210, 211 and 820 compliance)
  • A minimum of five (5) years relevant experience with quality systems including change control, incident management, and deviation management.
  • Prior experience with various quality systems software systems (e.g., LIMS, Trackwise, Documentum) development or administration preferred
  • Prior experience in the validation of computer systems for use in Good Manufacturing Practices (GMP) environment and creating and revising Standard Operating Procedures (SOPs) preferred
  • A minimum of two (2) years relevant computer systems validation and testing experience
  • Strong communication and presentation skills
  • Strong ability to facilitate discussions and negotiate mutually beneficial solutions when necessary
  • Willingness to travel 100% on a weekly basis to client locations

Company Information:

Clarkston Consulting is a mid-sized firm that delivers management, operations, and technology solutions to market leaders in the life sciences and consumer products and retail industries. For over 25 years Clarkston has worked as a direct partner and trusted advisor to our clients.

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