Quality Assurance Auditor Job Description

Quality Assurance Auditor Job Description

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Quality assurance auditor provides technical support to Quality, Engineering and Manufacturing regarding product and process inspection, audit, sampling plans, process controls and statistical applications.

Quality Assurance Auditor Duties & Responsibilities

To write an effective quality assurance auditor job description, begin by listing detailed duties, responsibilities and expectations. We have included quality assurance auditor job description templates that you can modify and use.

Sample responsibilities for this position include:

Performs packaging integrity compliance inspection
Updates pertinent information and data into the QA inspection logs
Must be able to work overtime when business requires
Provides constructive evaluation of quality related system investigations including manufacturing sites
Responsible for constant communication with senior leadership regarding quality monitoring results, any identified and/or recommended training needs and deficiencies, possible project improvement opportunities
Reports all Quality indicators for identification of trends to determine where training deficiencies exist
Engineering, construction, and/or nuclear plant experience
Excellent oral and written communication skills to effectively convey important information, facts, and ideas
Must meet requirements to obtain and maintain a Lead Auditor Certification pursuant to ASME NQA-1-1994, Supplemental 2S-3 and Appendix 2A-3
Performs facility inspections, critical phase inspections and data/report audits, which include monitoring for appropriate regulatory compliance, protocol and SOP compliance and reports findings to the appropriate staff and management

Quality Assurance Auditor Qualifications

Qualifications for a job description may include education, certification, and experience.

Licensing or Certifications for Quality Assurance Auditor

List any licenses or certifications required by the position: CQA, A&P, FAA, ASQ, WRT, IICRC, HACCP, HARPC, ISO, III

Education for Quality Assurance Auditor

Typically a job would require a certain level of education.

Employers hiring for the quality assurance auditor job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Associate Degree in Education, Life Science, Science, Chemistry, Business, Engineering, Associates, Management, Life Sciences, Auditing

Skills for Quality Assurance Auditor

Desired skills for quality assurance auditor include:

Microsoft Office applications
Business mathematics
Spreadsheet
CMS-HCC model and guidelines
Database applications
Word-processing
HEDIS / STARS
Guidelines
Inspection and audit methods and sampling techniques

Desired experience for quality assurance auditor includes:

Understand Adult Learning Theory with demonstrated ability to develop and present educational sessions
Understand coding classification systems such as ICD-9 CM, CPT, and HCPCS, MS-DRGs
Working knowledge of HCCs
Demonstrates an understanding of the operations and/or business of KP, health policy trends and any applicable regulatory requirements related to the responsible practice area
Knowledge of ISO 9001, 2000, MIL Standards, Defense contracts requirements such as FAR, DPAS
Minimum of 3 years of experience in internal audit

Quality Assurance Auditor Examples

1

Quality Assurance Auditor Job Description

Job Description Example
Our company is looking for a quality assurance auditor. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for quality assurance auditor
  • Discusses observations with site leadership to determine or evaluate corrective actions and responses and ensure compliance across the site
  • Tracks and reports on implementation of corrective actions
  • Lead investigative teams for supplier non-compliance and/or disqualification
  • Support adherence to Supplier Audit Plan
  • Manage and address Supplier Notifications of Change
  • Support supplier assurance budget adherence and tracking
  • Maintain site Approved Supplier List
  • Ensure quality compliance and cost effectiveness of the supply chain
  • Assist QA Managers with data/metrics for Corporate Review, Management Review, and Annual Product Reviews
  • Identify Quality Systems gaps by using process mapping and other applicable tools
Qualifications for quality assurance auditor
  • Quality assurance system auditing experience in a Government laboratory facility preferred
  • BS/BA with 2-5+ years of related experience in Biotech/Pharmaceutical industry, 2-5 years of audit experience in GMP environment preferred
  • Bachelor's Degree in a biological science, chemistry or equivalent and a minimum of 2 years of applicable laboratory experience
  • Ability to obtain/maintain certification in Chemical Personnel Reliability Program (NACLC required) and/or Biological Personnel Reliability Program
  • Ability to obtain/maintain a CDC security clearance
  • Experience with regulatory or other appropriate guidance documents, GLP regulations
2

Quality Assurance Auditor Job Description

Job Description Example
Our company is searching for experienced candidates for the position of quality assurance auditor. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for quality assurance auditor
  • Collect and compile statistical quality data as requested by the QA Supervisor
  • Assure all related product samples are collected according batch records requirements
  • Support the Quality Assurance Sr
  • Evaluate current operating procedures and recommend changes to management to optimize quality oversight and production activities
  • Prepare required reports to communicate outcomes of quality activities (Shift Report, Documentation Error Trending Report )
  • Perform activities related to quality indicators to improve the manufacturing batch record documentation process to assure compliance with regulations agencies and J&J Standards
  • Provide QA support for complaint investigations review and Change Control related to process
  • Scheduling and performing Internal Audits per AS 9100
  • You will work within our busy QA team to assure management that the company’s GMP activities comply with relevant international regulations
  • Create and lead the QA functions for the PQ Lab Team
Qualifications for quality assurance auditor
  • Requires contact with customers and suppliers
  • Requires formal presentation to co-workers and customers
  • Requires a high level of attention to detail
  • A full complement of business computer literacy skills (e.g., work processing, spreadsheets, databased software ) is preferred
  • ASQ CQA (preferred)
  • Occasional bending, grasping, climbing ladders/steps, carrying, stopping, kneeling, crouching
3

Quality Assurance Auditor Job Description

Job Description Example
Our company is growing rapidly and is searching for experienced candidates for the position of quality assurance auditor. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for quality assurance auditor
  • Presents and reviews audit outcome results and analysis with the management team
  • If necessary, in conjunction with the management team, establish corrective action plans to address documented quality deficiencies
  • Implements corrective action plans in coordination with clinical supervisors as needed
  • Monitors, tracks and documents effectiveness of any implemented quality improvement action plans
  • Reports and reviews results of quality improvement interventions with the management team
  • Continues quality improvement interventions as needed
  • Performs quality monitoring of live and/or recorded calls to ensure department quality objectives are achieved with the established frequency of audits
  • Familiarity with Empower 3 software and at least one scientific technique (HPLC, GC)
  • Assist/ participate in APQP activities on existing or new programs for process capability studies, gauge R&R, PPAP sample run parts, trials
  • Observe standards for safe working conditions as outlined in the Occupational Health & Safety Act, the rules and regulations outlined in the Employee Handbook
Qualifications for quality assurance auditor
  • Familiar with risk and root cause analysis
  • Only online applications will be considered
  • Comprehensive knowledge of products, regulatory standards
  • University degree/college diploma in mechanical, manufacturing or process engineering, or equivalent industry experience
  • Must have strong organizational and mathematical skills
  • Must have knowledge of medical terminology, ICD-9, CPT-4, treatment of diagnoses, and COB
4

Quality Assurance Auditor Job Description

Job Description Example
Our growing company is searching for experienced candidates for the position of quality assurance auditor. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for quality assurance auditor
  • Assist in document management activities
  • In GLP facilities, review and approve all procedures related to production and maintenance, approving or rejecting incoming materials, in-process materials and finished product
  • Participate in the preparation and review of study and QA files in preparation for sponsor site visits and regulatory inspections
  • Develop recommendations for corrective and preventative actions to respond to client visit and regulatory inspection findings
  • Analyze and recommend improvements to PW internal unit, supplier and Designated Service Provider (DSP) metrics and results
  • Analyze and recommend supplier/DSP actions based on audits, risk score and other quality performance
  • Perform audits to AS9110 and worldwide aftermarket National Aviation Administrations (NAA/145) requirements
  • Assist participate with senior PW management to re-define the CE-Aftermarket Supplier minimum quality assurance requirements
  • Ensure that POCRL activities conform with the requirements of the laboratory QMS
  • Draft, review and approve continuing quality improvement documentation
Qualifications for quality assurance auditor
  • ISO experience (15189 - Used in Medical Laboratories highly preferred)
  • GCP experience preferred
  • Bachelor's degree in business or related field of study or an equivalent combination of education and experience
  • 3-5 years' experience within the claims adjusting industry
  • Minimum of five years' experience auditing and analyzing, or adjusting claims
  • Knowledge of branch and regional claims operations
5

Quality Assurance Auditor Job Description

Job Description Example
Our company is looking to fill the role of quality assurance auditor. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for quality assurance auditor
  • Analyze Grievance & Appeals case information to ensure compliance of all CMS regulations and contractual guidelines
  • Ensure that applicable equipment and systems are installed properly and receive adequate quality checkout through careful site observation and verification of contractor's quality control documentation
  • Verify and document all systems are properly submitted and installed as intended per industry standard and specifications by witnessing and documenting throughout the construction process
  • Ensure that the as-built drawings, closeout documentation, comprehensive systems manual for turnover to the Owner during the closeout is in compliance with specifications
  • Delegate break times to and fill in when needed for line workers
  • Perform conduct Elmendorf tear and dart drop tests
  • Complete inventory checks regularly
  • Adjust production procedures to ensure quality standards are met
  • Perform assessments of audit activities to evaluate the quality of documentation supporting execution of audit work
  • Analyze deficiencies to drive action and improve quality
Qualifications for quality assurance auditor
  • Bachelor’s Degree in food science, Microbiology or food process engineering
  • Ability to wear Personal Protective Equipment (PPE) (ear plugs, hard hats, coveralls, smocks, gloves, goggles, and other GMP required equipment
  • Minimum 2 years previous experience measuring work standards and applying quality assurance principals
  • Minimum 2 years developing project plans, audit reports, summaries and presentations to management
  • Required to qualify for and maintain a current SIDA Badge
  • Extensive knowledge of Excel and PC skills are required including Power Point presentations

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