Senior Quality Analyst/Engineer

Job ID
133592
Job Type
Contract
Industry
Manufacturing
Location
Madison, Wisconsin, United States

Talascend is currently seeking a Senior Quality Analyst/Engineer for a contract opportunity with our client in Madison, Wisconsin.

Overview

The Senior Quality Analyst/Engineer is responsible for assuring that activities, processes, and product related to managing the processes of CAPA, Change Management, investigations, deviations, Quality Management Review, Audit coordination, and metrics for the facility.

Responsibilities

  • Develop and maintain quality system processes, including metrics reporting and tracking
  • Manage CAPA initiation, review, surveillance, and reporting
  • Facilitate the site Quality Management reviews
  • Facilitate and lead the site Change Management process
  • Support and lead root cause analyses through cross functional team involvement
  • Leading Good Documentation Practice training and Quality on the Floor coordination and performance
  • Interpret and properly apply all applicable regulatory requirements
  • Coordinate and provide direct support for facility audits by internal and external entities
  • Manage data collection and reporting when product recalls are required
  • Perform trending of Quality Systems to support FDA and Management reviews
  • Improve quality culture through site initiatives and improve existing procedures to better align with regulatory requirements
  • Review and approval of procedures, protocols, reports, etc., as required.

Qualifications

  • Bachelors, or higher, degree in science/technology program preferred
  • 5+ years of Quality Assurance experience in a cGMP Quality Assurance/Compliant environment

Requirements

  • Effective communication, coaching/mentoring, and presenting skills
  • Ability to manage change
  • Self-motivated
  • Independent and sound decision making capabilities
  • Project management to deliver on time results
  • Leadership skills / Emotional Intelligence
  • Ability to utilize statistics at a moderate level for trending and interpretation of statistical data
  • Proficient with Microsoft Office tools, especially Excel, Word and Powerpoint
  • Technical writing
  • Statistical analysis - Minitab or other software equivalent, preferred
  • Domestic and international travel will be required on a limited basis

Shift

Onsite during normal working hours M-F, but may be required to work extra hours or on weekends or holidays.




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We thank all applicants for their interest. However, only those qualified individuals who closely meet the qualifications of the position will be contacted. The details of the position are only a summary, other duties may be assigned as necessary.

Background Check and Drug Screen may be required.

Apply Now

Talascend is an Equal Opportunity Employer that recruits and hires qualified candidates without regard to race, religion, sex, sexual orientation, gender identity, age, national origin, ancestry, citizenship, disability, or veteran status.

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