Summary
Overview
Work History
Education
Skills
Languages
Timeline
Generic

Jake Brugger

Salt Lake City,UT

Summary

Adaptable and resourceful knowledge-seeker with expertise in regulatory compliance, quality control, and technical systems. Proven ability to coordinate cross-functional teams to support complex clinical trials and medical device development. Detail-oriented with strong analytical thinking skills, ensuring data and documentation integrity and timely project delivery in full compliance with multiple regulatory bodies.


Overview

10
10
years of professional experience

Work History

Associate Project Manager I

ARUP Laboratories
10.2022 - Current
  • Collaborated closely with senior project managers to ensure timely and accurate disclosure of laboratory results and regulatory documentation to pharmaceutical sponsors and regulatory bodies.
  • Collaborated with subject matter experts to conduct data analysis and risk assessments, ensuring compliance with established procedures.
  • Implemented Good Clinical Practices (GCP) and Medical Device Design Control standards and requirements as warranted by project scope.
  • Coordinated cross-functional teams to successfully achieve project milestones and objectives in support of pharmaceutical clinical trials and medical device development and adoption.
  • Liaised with pharmaceutical sponsors, various laboratory sections, and senior management to ensure data quality and adherence to deliverable schedules.

Quality Control Specialist I

ARUP Laboratories
02.2021 - 09.2022
  • Ensured document and data compliance to good documentation practice, internal, and external quality quality control standards.
  • Performed QC review of reagent preparation documents, clinical data files, and laboratory run folder documentation in support of clinical investigations.
  • Performed QC review of development and validation documentation for bioanalytical assays and PharmaDx PDP projects.
  • Ensured documentation was corrected in accordance with good documentation practice by responsible individuals to maintain accurate, accountable, and contemporaneous documentation.
  • Created and maintained QC and reagent control trackers.

Server

Ruth's Chris Steakhouse
04.2015 - 02.2021
  • Demonstrated strong multitasking skills by managing multiple patrons simultaneously without compromising service quality or timeliness.
  • Worked with POS system to place orders and to manage and reconcile charges for restaurant accounting.
  • Assisting patrons with liquor and wine pairings in an upscale atmosphere with discerning clientele.
  • Collaborated with a strong management and kitchen team which saw consistent sales growth for 32 quarters.
  • Liaised between different teams, management, and patrons simultaneously.

Education

Bachelor of Arts - English Language And Literature

University of Utah
Salt Lake City, UT
12-2015

Bachelor of Arts - German Language And Literature

University of Utah
Salt Lake City, UT
12-2015

Skills

  • Deep familiarity with HIPAA, CAP-CLIA, US CFR 21, FDA, IVDR regulations
  • CITI certified: Human Research, Group 1Biomedical Research Investigators and Key Personnel
  • CITI Certified: Good Clinical Practice (US FDA Focus)
  • Microsoft Suite
  • Cerner LIS, Artel, REES, and LIMS
  • Analytical thinking
  • Task delegation
  • Quality control
  • Detail-oriented
  • Attention to detail
  • German Language: full professional proficiency
  • Spanish language: elementary proficiency

Languages

English
Native or Bilingual
German
Full Professional
Spanish
Elementary

Timeline

Associate Project Manager I

ARUP Laboratories
10.2022 - Current

Quality Control Specialist I

ARUP Laboratories
02.2021 - 09.2022

Server

Ruth's Chris Steakhouse
04.2015 - 02.2021

Bachelor of Arts - English Language And Literature

University of Utah

Bachelor of Arts - German Language And Literature

University of Utah

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