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compliance and quality consultant resume example with 18 years of experience

Jessica
Claire
resumesample@example.com
(555) 432-1000,
Montgomery Street, San Francisco, CA 94105
:
Professional Profile

Client focused Quality and Compliance Consultant with experience in complaint handling, MDR submissions (Form 3500A), remediation efforts in response to 483 and Warning Letters, records management, CAPA, Project Management, HACCP, Good Documentation Practices, and FDA 21 CFR Part 11, 812, 803, 806


Experience in the following computer applications:

MS Word/ Office, Excel, PowerPoint, Outlook, Lotus Notes, Adobe Acrobat


SAP, Trackwise, ETQ, Post Market Data Analysis (PMDA)

Education
University of Illinois Urbana, IL Expected in BS : Food Science Human Nutrition/ Dietetics option - GPA :
Experience
Gryphon Technologies - Compliance and Quality Consultant
Norfolk, VA, 09/2013 - Current
  • Lead complaint handling remediation efforts for medical devices
  • MDR reportability assessments
  • FDA E-submissions and paper submissions of safety adverse events and reportable product complaints via FORM 3500A
  • Review of resource documentation (service records and adverse event reports)
  • Review and updates of Risk Management (Risk Analysis) Design FMEA, Use FMEA, Process FMEA
  • Investigational writing relating to complaint trending outcomes and failure modes of medical devices Root Cause Analysis (Fishbone, 5 Whys, Is/is not, Pareto)
  • Perform all work in accordance with applicable Federal regulations and Internal Standard Operation Procedures, FDA and MDD regulations
  • Perform projects and assignments as delegated.
Alutiiq Llc - Product Surveillance Quality Associate
Greenbelt, MD, 08/2007 - 03/2013
  • Collects necessary complaint information and enters information into data system
  • Answers calls from facilities regarding issues, investigates and provides resolution
  • Determines reportability of complaints to the FDA
  • Identifies Adverse Events and sends Global Pharmcovigilance notification
  • Assists in processing of high-risk complaints
  • Manages workflow; identifies and escalates issues
  • Participates in process improvement activities and projects (CRB member)
  • Adheres to highly regulated Internal procedures and FDA guidelines
  • Handles entire population of complaints for 2 medical devices
  • Participates in Audit Functions- Internal and FDA
  • Prepares daily assignments for the team
  • Assists Team Lead with required duties
  • Verifies the accuracy of Medication Delivery and Renal complaint files
  • Reviews and offers suggestions for updates and improvements to SOPs and Corporate Quality Procedures
  • Participates in CAPA functions.
Drug Information Association Inc - Associate Nutritionist
Conroe, TX, 07/2006 - 08/2007
  • Determines WIC eligibility based upon dietary, anthropometric, clinical and health history data in accordance with established policies and procedures
  • Nutrition counseling, breastfeeding support and follow up for WIC clients as well as issuance of WIC food instruments
  • Documentation of clinical information in Cornerstone system including nutrition care plans in client's chart in the form of S.O.A.P notes
  • Development and presentation of nutrition education and in-service training for clients, clinic staff and the surrounding community.
Davis Street Land Company - Office Manager, Administrative Assistant
City, STATE, 01/2005 - 09/2006
  • Responsible for various projects for property management, marketing, legal, leasing and accounting departments
  • Supply ordering, mail distribution, event planning, meeting preparation, and receptionist duties
  • Monitored and operated office security system as well as network backup.
Colorado Technical University Online - Admissions Advisor, Team Leader
City, STATE, 11/2003 - 02/2005
  • Successfully met specific daily, weekly and monthly sales goals for contacting,.
  • interviewing, qualifying, enrolling and starting students.
  • Guided and oversaw a team of 10 Admissions representatives to ensure team success.
  • Performed general office duties: faxing, filing, data entry, Excel file creation.
Jenny Craig - Program Consultant
City, STATE, 06/2003 - 11/2003
  • Consulted daily with clients to create menu plans and to discuss achievable weight loss.
  • goals.
  • Responsible for client retention and renewal as well as program sales and presentations.
  • Assisted Centre Director with inventory control as well as vendor relations.
Aramark, Evanston Northwestern Healthcare - Dietetic Technician
City, STATE, 08/2002 - 03/2003
  • Interacted daily with nursing staff, clinical dietitians and physicians to discuss.
  • patient diet orders.
  • Participated in patient education and meal rounds.
  • Resolved patient issues effectively and efficiently while running the diet office.
Skills

Self-motivated, client focused, goal oriented, proactive individual, persistent in achieving results, able to work independently or as part of a team, ability to successfully multi-task, excellent communication and problem solving skills


Junior Achievement and Habitat for Humanity Volunteer

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Resume Overview

School Attended

  • University of Illinois

Job Titles Held:

  • Compliance and Quality Consultant
  • Product Surveillance Quality Associate
  • Associate Nutritionist
  • Office Manager, Administrative Assistant
  • Admissions Advisor, Team Leader
  • Program Consultant
  • Dietetic Technician

Degrees

  • BS

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