Technical Product Quality Assurance

KRISTEN BOUCHE **********@*****.*** 781-***-****

www.linkedin.com/in/kristen-bouché Boston, MA, 02127 PROFESSIONAL SUMMARY

ACCOMPLISHED IN LEADING BIOGEN'S TECHNICAL PRODUCT COMPLAINTS TEAM, SPEARHEADING DATA ANALYSIS PROJECTS DEMONSTRATING PROFICIENCY IN POWER BI AND TABLEAU, WHERE I EXCEL IN TRANSFORMING COMPLEX DATA INTO ACTIONABLE INSIGHTS AND ENHANCING COMPLIANCE STANDARDS WITH PATIENT SAFETY ALWAYS IN MIND.

■ Data Analytics: Proficient in creating Tableau graphs, PowerBI, SQL, Agile, Microsoft Office

■ GMP QMS Documentation: Created and reviewed numerous Technical Reports, APRs,

■ Audit Support: Supported ISO audits

■ Training: Vendor and Patient Services liaison, created eLearning to streamline EXPERIENCE

BIOGEN Cambridge, MA April 2015 – October 2024 Sr Associate I, Quality Assurance Technical Product Complaints

Lead data analysis project teams independently, initiating and implementing changes and improvements

Manage relevant software applications, training, and development of team members Assume management responsibility as needed

Generate and run regular and ad hoc global metrics of product complaint quality system data

Schedule team outings to foster greater collaboration and engagement

Identify high-profile product complaint trends and coordinate full investigations, including cross-functional communication with multiple Biogen departments and external manufacturers

Perform internal laboratory audits to ensure compliance and safety standards

Assist upper management with new product launches, ensuring current processes and IT systems are equipped to handle future product complaint reports. Associate III, Quality Assurance Technical Product Complaints

Received CEO award for pioneering customer-focused initiatives

Served as training coordinator and liaison between patient support groups, including Patient Services, Nursing, and Vendors

Implemented onboarding process for new hire patient support groups into TrackWise database, reducing case entry time

Created eLearning modules and training videos Developed and presented dashboards using Tableau to Affiliates and Patient Support teams

Served as Data Analysis and Complaint Intake SME for the TPC group

Presented product complaint data at Quarterly Management Review meetings. Associate II, Quality Assurance Technical Product Complaints

Coordinated monthly reports distributed throughout Biogen departments Acted as training liaison for patient support groups

Wrote Annual Product Review (APR) Reports for Biogen products

Spearheaded a project to reduce time spent on duplicate reports. Associate I, Quality Assurance Technical Product Complaints

Delivered expertise in Biogen Technical Product Complaint function, processing various Technical Product Complaint cases

Coordinated case investigations, ensuring global consistency and compliance

Handled and analyzed Technical Product Complaint sample returns, coordinating additional evaluations with outside sources

Wrote, reviewed, and evaluated SOPs concerning the Technical Product Complaint Quality System

Generated and ran regular and ad hoc global metrics of Quality System data for Technical Product Complaint use.

Dana Farber Cancer Institute Boston, MA September 2014 - April 2015 QA/QI SPECIALIST II

Worked as a Data Specialist with Engraftment Data on various databases, including CIBMTR, FileMaker, and electronic data forms

Conducted trending and analysis of data using appropriate quality and statistical tools

Reported data within Dana Farber as well as externally to various government agencies

Performed audits to ensure compliance with standards, regulations, procedures, and policies.

EDUCATION

BS in Biology, Salve Regina University Newport, RI September 2005 - May 2009

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