Auditor Quality Assurance Resume Sample

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Gracie Gleason
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Work Experience


Senior Auditor, Quality Assurance
05/2016 - PRESENT
San Francisco, CA
  • Audit inventory for compliance with Converse and customer’s requirements
  • Perform Audits in both facilities
  • Have at least 5 years quality assurance experience in microbiology/diagnostic CLIA certified laboratories, medical device manufacturing, pharmaceutical industry, or similar
  • Demonstrated interpersonal and management skills with ability to work collaboratively with other scientists and laboratorians
  • Support UAT assignments for IA’s toolkit (AIMS)
  • As part of our JetBlue Continuing Analysis and Surveillance System (CASS), performs analysis of audit findings or reliability reports for trends that involve the services or JetBlue’s business partners
  • Four (4) years’ experience in a 14 CFR Part 121 Air Carrier Quality or Maintenance environment (military experience can be used in lieu of 121 experience)
Quality Assurance Internal Auditor
12/2010 - 03/2016
Detroit, MI
  • Possess and maintain a valid Driver License and a driving record that meets JetBlue Airways’ insurance standards
  • Works with the QA Manager to develop, implement, monitor and manage the company’s compliance with internal control requirements
  • Analyze & underwrite loans for adherence to Ocwen’s and agency guidelines
  • Audit Operations departments’ processes for adherence to internal policies and procedures, performance quality, and state and federal guidelines through monitoring Operations department documentation
  • Prepare and sign a statement to be included with the final study report which shall specify the date’s inspections were made and findings reported to management and to the study director
  • Pass a ten (10) year background check, pre-employment drug test, and criminal history records check (CHRC)
  • Produce weekly, monthly, quarterly and annual management and operations focused reports
Quality Assurance Customer Care Auditor
10/2008 - 11/2010
Boston, MA
  • Assist in developing and maintaining dashboard to report Corporate and Client Quality results
  • Conduct site client audits as directed by QA Management, to present overall quality systems and procedures, and handle audit responses in a satisfactory and timely manner
  • Document audit observations in MasterControl audit module
  • Drive closure of CAPA resulting from audits
  • Communicate with clients on compliance issues and corrective action surrounding PHL audits
  • Participate in regulatory and accreditation audits and inspections as directed by QA Management
  • Conduct internal, external and vendor/supplier audits as directed by QA Management
  • Participate in the development of site and corporate compliance policies, procedures and documents

Education


Mayville State University
2003 - 2008
Bachelor's Degree in Biology

Professional Skills


  • Excellent interpersonal, verbal, and written communication skills, including ability to present at conferences, meetings, training sessions
  • Excellent time management skills and the ability to follow-up on multiple tasks and projects
  • Computer skills- ability to learn new systems quickly
  • Experience using measurement equipment, generating and organizing quality data for quality decision-making
  • Flexibility and ability to adjust to changing priorities and unforeseen events
  • Competent with strong problem solving and negotiation
  • Experience in GLP and GMP

How to write Auditor Quality Assurance Resume

Auditor Quality Assurance role is responsible for compliance, training, auditing, reporting, manufacturing, design, research, insurance, travel, events.
To write great resume for auditor quality assurance job, your resume must include:

  • Your contact information
  • Work experience
  • Education
  • Skill listing

Contact Information For Auditor Quality Assurance Resume

The section contact information is important in your auditor quality assurance resume. The recruiter has to be able to contact you ASAP if they like to offer you the job. This is why you need to provide your:

  • First and last name
  • Email
  • Telephone number

Work Experience in Your Auditor Quality Assurance Resume

The section work experience is an essential part of your auditor quality assurance resume. It’s the one thing the recruiter really cares about and pays the most attention to.
This section, however, is not just a list of your previous auditor quality assurance responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular auditor quality assurance position you're applying to. The work experience section should be the detailed summary of your latest 3 or 4 positions. Representative Auditor Quality Assurance resume experience can include:

  • Good written and oral communication skills with all levels of employees
  • Demonstrates reliability by arriving to work on time and by abiding by the attendance policy
  • Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Monitors own work to ensure quality is met
  • At least six years of relevant experience required
  • Using APRISe, track and trend non-conformances and determine long term corrective actions
  • Maintain batch manufacturing record files according to storage procedures

Education on an Auditor Quality Assurance Resume

Make sure to make education a priority on your auditor quality assurance resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your auditor quality assurance experience. For example, if you have a Ph.D in Neuroscience and a Master's in the same sphere, just list your Ph.D. Besides the doctorate, Master’s degrees go next, followed by Bachelor’s and finally, Associate’s degree.

Additional details to include:

  • School you graduated from
  • Major/ minor
  • Year of graduation
  • Location of school
These are the four additional pieces of information you should mention when listing your education on your resume.

Professional Skills in Auditor Quality Assurance Resume

When listing skills on your auditor quality assurance resume, remember always to be honest about your level of ability. Include the Skills section after experience. Present the most important skills in your resume, there's a list of typical auditor quality assurance skills:

  • Strong computer skills are required with good working knowledge of MS Office Suite
  • Good knowledge of international regulatory requirements and industry guidelines governing global GCP (ICH, EMA, FDA, MHRA, PMDA) required
  • Ensures clear, concise, evidence-based rationales have been provided in support of all recommendations and/or determinations
  • Working knowledge of regulations
  • Understanding of the AS9100 Standard
  • Draw conclusions, considering the ‘big picture’/ combining details to understand process(es) / issue(s)

List of Typical Experience For an Auditor Quality Assurance Resume

1

Experience For Quality Assurance Internal Auditor Resume

  • System/ Process Audits
  • Trial Master File
  • The Auditor is responsible for leading and conducting audits to insure that all management and employees throughout the Enterprise are in conformance to the company Quality Management System and high work standards to ensure that all activities meet or exceed all business goals, customer/industry/regulatory requirements and SNC process and procedures
  • The Auditor is responsible for leading and conducting audits to insure that all management and employees throughout the Enterprise are in conformance to the company Quality Management System and high work standards to ensure that all activities meet or exceed all business goals, customer/industry/regulatory requirements and SNC process and procedures.

List of Typical Skills For an Auditor Quality Assurance Resume

1

Skills For Quality Assurance Internal Auditor Resume

  • Verifies that the peer reviewer has attested to only the fact(s) and that no evidence of reviewer conflict of interest exists
  • Experience in Excel
  • Participate in various continuing education requirements and or training activities
  • Thorough working knowledge of Regulatory Compliance, Quality System Management and Quality Assurance principles and practices
  • Assume a contributing role in compliance projects and participate in corporate and site strategic meetings
  • Includes the appropriate management in decision-making process
  • Interact professionally at multiple levels within a client-oriented organization
2

Skills For Auditor, Quality Assurance Resume

  • Willingness to work with multiple supervisors in a matrix environment and to value the importance of teamwork
  • Work professionally with highly confidential information
  • Diplomatically address sensitive issues confidentially and professionally
  • Work consistently in a fast-paced environment
  • Understand, apply, and explain concepts
3

Skills For Quality Assurance Customer Care Auditor Resume

  • Conduct risk-based GCP audits across all phases of Clinical Research including, but not limited to project related audits, system audits, supplier audits, pharmacovigilance (PV) audits
  • Local, regional or global consultancy with regard to the implementation of GCP and PV requirements, and implementation of regulatory requirements in these areas
  • Provide support and resources for regulatory inspections & sponsor audits
  • Liaise with external industry and regulatory inspectorate contacts and networks to determine best practice with regard to implementation of GCP and PV requirements across the PAREXEL Corporation
  • Evaluates clinical information received, writes and/or reviews various reports including Medical Record Reviews, Medical Record Chronologies, Provider Bill Reviews, Coding Reviews, Hospital Bill Reviews, List of Missing Records, Medical Bill Apportionments, Mock Billing Invoice and Medical Summary Statements
  • Performs quality assurance review of peer review reports, correspondences, addendums or supplemental reviews
  • Ensures that all client instructions and specifications have been followed and that all questions have been addressed
4

Skills For Quality Assurance & GLP Auditor Resume

  • Ensures each review is supported by clinical citations and references when applicable and verifies that all references cited are current and obtained from reputable medical journals and/or publications
  • Ensures the content, format, and professional appearance of the reports are of the highest quality and in compliance with company standards
  • In IME or Peer Review cases, ensures the appropriate board specialty has reviewed the case in compliance with client specifications and/or state mandates and is documented accurately on the case report
  • Ensures the provider credentials and signature are adhered to the final report
  • Identifies any inconsistencies within the report and contacts the Peer Reviewer to obtain clarification, modification or correction as needed
  • Assists in resolution of customer complaints and quality assurance issues as needed
  • Ensures all federal ERISA and/or state mandates are adhered to at all times
  • Provides insight and direction to management on consultant quality, availability and compliance with all company policies and procedures and client specifications
  • Promote effective and efficient utilization of company resources
5

Skills For Quality Assurance Enrollment Auditor Resume

  • Summarizes clinical information received, including Medical Record Reviews, Medical Record Chronologies, Provider Bill Reviews, Coding Reviews, Hospital Bill Reviews, List of Missing Records, Medical Bill Apportionments, Mock Billing Invoice and Medical Summary Statements
  • Manage multiple and varied tasks, and prioritize workload
  • Specific vision requirements including reading of written documents and use of computer monitor screen frequently
  • Supervisory/ Management Responsibility: N/A
  • Develop relationships with a culturally diverse group of key stakeholders within PAREXEL and the client’s business
  • RRSP Match, DFSP Contribution
  • Write and revise documents. Ability to use judgment in situations for which there are no precedents
6

Skills For Quality Assurance Prefund Auditor Resume

  • Two years’ experience handling multiple simultaneous assignments with minimal supervision and in coordinating activities with various levels of management
  • Fosters a good working relationship with internal and external clients
  • Plan and conduct audits, including global and complex assignments, delivering a written report
  • Maintain QA oversight and deliver QA consultancy for assigned countries/departments
  • GCP Late Phase Investigator Site Audits
  • Know & follow MD and client policies & procedures related to work activities performed in area of responsibility
  • Prepare and maintain essential databases, such as metal reject reports, QA product labels and release chart; copy and distribute data
  • Maintain knowledge of WuXi policies, procedures and directives as well as US and international regulations and guidelines associated with PHL services
  • Participate in cross-site projects
7

Skills For Auditor, Originations Quality Assurance Resume

  • Provides back-up for the QA department in selected areas as needed
  • Travels as required by the company
  • Follows instructions; Responds to managements directions; Completes all work assigned by the Manager of OPO Review Services
  • Assesses own strengths and weaknesses; Pursues training and development opportunities; Strives to continuously build knowledge and skills; Shares expertise with others
  • Adapts to change in work environment; Ability to deal with change, delays, or unexpected events
  • Able to identify, define and explain day-to-day problems and solutions
8

Skills For Senior Auditor, Quality Assurance Resume

  • Customer Relations – When required assist in investigations of external and internal nonconformances and prepare investigation reports for management
  • Financial Accountability – Manage travel costs and continuous working with other department personnel to achieve an orderly approach to developing an audit schedule that divides areas of the country that achieves the best use our auditing personnel’s time
  • Problem Resolution – Pro-actively apply problem solving skills to a) clearly identify the problem; b) use data / facts to determine governing requirement for the investigation of root cause so that the locations can make the proper corrective action
  • Reporting Requirements – Send all Internal Audit reports to management as required per SNC’s Audit Procedures. Track and approve Internal Audit replies. Directly reports to Corporate Director of Product Assurance and Safety
  • Knowledge and utilization of AS9100, ISO 9001 and other applicable Military and statutory Standards and Specifications
  • Working in a Quality Management System in understanding, following and enforcing compliance as an Auditor. Aid and develop all work processes to ensure all employees meet or exceed customer, SNC, industry or regulatory requirements
9

Skills For Quality Assurance Senior Auditor Resume

  • Experience at conducting
  • ISO Lead Auditor certification is mandatory; aviation-related background highly desired
  • Customer Relations – When required assist in investigations of external and internal nonconformances and prepare investigation reports for management.
  • Financial Accountability – Manage travel costs and continuous working with other department personnel to achieve an orderly approach to developing an audit schedule that divides areas of the country that achieves the best use our auditing personnel’s time.
  • Problem Resolution – Pro-actively apply problem solving skills to a) clearly identify the problem; b) use data / facts to determine governing requirement for the investigation of root cause so that the locations can make the proper corrective action.
  • Reporting Requirements – Send all Internal Audit reports to management as required per SNC’s Audit Procedures. Track and approve Internal Audit replies. Directly reports to Corporate Director of Product Assurance and Safety.
  • Interface directly with on-site Customer representatives for matters pertaining to the Quality Management System
10

Skills For Quality Assurance Field Auditor Resume

  • Review Customers applicable command media for specific aircraft maintenance documentation to assure Repair Station compliance
  • Perform scheduled and un-scheduled internal surveillance audits for the Repair Station to ensure compliance with title 14 of the Code of Federal Regulations (CFR), EASA 145, AAR & Customer Policies and Procedures
  • Lead, or assist in Root Cause Corrective Action (RCCA) meetings
  • Maintain the Repair Station Quality Safety Management Systems (QSMS) program
  • Work within the AAR Electronic Company Performance System (APRISe)
  • Familiar with AS9001-2015 & AS9110, or similar standards
  • Familiar with 14 CFR part 145

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