QA Auditor Job Description

QA Auditor Job Description

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QA auditor provides sound advice and interpretations related to current GxP guidelines and regulations to Senior Management and employees.

QA Auditor Duties & Responsibilities

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

Sample responsibilities for this position include:

Plans and executes Quality Assurance strategies within the Software Development Life Cycle
Works closely with project teams to ensure that test designs for new features address core elements of risk
Ensures that test plans and test results are clearly documented and communicated
Works with project teams to develop, maintain and execute test cases and scripts in support of regular software releases
Conducts Quality Assurance audits in the Distrib Center in order to assure that company standards are maintained and product integrity is preserved
Determines overall plant product quality by conducting and evaluating various product tests related to packaging
Retains Quality records as needed
Conducting quality assurance (audit planning memo, report, work-paper reviews) during/after audits
Working for the creation and implementation of various new frameworks within the department, such as staff skill assessment, training program, fame-work of risk assessment of audit entities, fame-work of annual audit plan, enhanced continuous auditing or other various metrics analysis
Quality Assurance Reviews (QARs) on the basis of criteria defined under QAIP on sample missions

QA Auditor Qualifications

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

Licensing or Certifications for QA Auditor

List any licenses or certifications required by the position: ICD10, ASQ, WRT, IICRC, TQM, ISO, NFN, RQAP-GLP, GLP, RQA-GCP

Education for QA Auditor

Typically a job would require a certain level of education.

Employers hiring for the QA auditor job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Associate Degree in Science, Engineering, Technical, Education, Chemistry, Biology, Life Science, Associates, Medical, Medicine

Skills for QA Auditor

Desired skills for QA auditor include:

GxP and appropriate regional research regulations and guidelines
At least two
Medicaid
GCP guidelines and relevant regulations for the conduct of clinical trials
NH Family
Current Code of Federal Regulations and other FDA regulations and guidance’s
Current Good Manufacturing Practices
United States Pharmacopea
Database applications
Spreadsheet

Desired experience for QA auditor includes:

Discuss with Audit Supervisor and Head of Mission the queries raised under review
Issue individual QAR report for each mission indicating report rating and improvement areas to be considered in future mission
Issue overall QAR report at the end of reviews highlighting improvement themes for the entire department
Prepare and report synthesis to Head of Internal Audit and Regional Executive Committee along with recommendations for each findings
Provide management oversight for and participate in Internal Clinical Development, Biometrics, Medical Affairs and Drug Safety Systems Audits
Provide oversight of CQA auditors and contract auditors to develop specific audit plans, review and assess internal and external audit reports to ensure they have met the audit plan and that recommendations and suggested Corrective Action Preventative Action Plans (CAPA) are adequate all to ensure compliance with Standard Operating Procedures (SOPs), Regulations, and Best Practices

QA Auditor Examples

1

QA Auditor Job Description

Job Description Example
Our innovative and growing company is looking for a QA 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 QA auditor
  • Review, verify and approve production paperwork in order to facilitate release of customer shipments
  • Communicate paperwork issues to operations, if necessary
  • Record data for internal analysis of finished goods
  • Communicate with Project Managers and Customers, if necessary
  • Communicate Company policies, procedures, and customer requirements to other RTMD employees and to participate/assist in their development as needed
  • Assigned overtime is mandatory
  • Conduct complex internal and/or external audits and inspections to ensure compliance with established quality assurance processes, standards, global regulatory guidelines and/or client contractual obligations
  • Identify issues impacting the quality and/or integrity of clinical research programs, determines root cause of non-conformance and develops strategies to address issues
  • May perform technical document review and other GMP practice activities in support of clinical development programs
  • Provide audit reports to management
Qualifications for QA auditor
  • Ability to review and evaluate data / records
  • BA/BS in relevant field and 1 year of relevent experience
  • Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds
  • Ability to communicate complex information and ideas so others will understand
  • Plan and deliver quality services for contracted quality assurance audits, internal site audits, laboratory and file audits for clients and projects
  • Light to moderate lifting and carrying computer with a maximum lift of 15-20 lbs
2

QA Auditor Job Description

Job Description Example
Our growing company is looking for a QA 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 QA auditor
  • Review existing SOPs/project specific plans and audit processes to ensure that staff are compliant with process
  • Create/develop and present training to staff on applicable regulatory requirements
  • Document audit findings/observations/recommendations in an audit report
  • Track audit responses from teams
  • Review audit findings/observations/recommendations and identify process improvement initiatives
  • Manage and/or conduct process audits in all functional areas
  • Attend project team meetings, as necessary
  • Manage/coordinate the process of on-site Sponsor and Regulatory Audits – ensure regulatory inspection readiness
  • Assist in and successfully perform all regulatory document reviews
  • Assist the QA Manager in the recording of Score card data for NY QA areas (15% of overall business)
Qualifications for QA auditor
  • Assist with preparation, conduct and follow up of sponsor and regulatory audits and represent the QA corporate systems compliance unit
  • Proven experience in Quality Assurance within a CRO or Pharmaceutical company
  • Knowledge of ICH GCP Guidelines, EU and FDA Regulations Guidelines on Good Pharmacovigilance Practice (GVP) OR Good Clinical Practice (GCP)
  • Strong client auditing experience
  • Advanced training in clinical Quality Assurance
  • Audit skill and/or certification is preferred
3

QA Auditor Job Description

Job Description Example
Our innovative and growing company is looking to fill the role of QA auditor. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for QA auditor
  • Conduct Store Performance Audit, SPA, in all brand stores
  • Record SPA Results and communicate to QA management
  • Discuss Work man-hour management daily
  • Conduct Pre-Production Samples, PPS, Review & Disposition and record and communicate results to the appropriate teams
  • Correctly mark Approved Sample & QA Style Folder- for use by third party auditor
  • Prepare & Assist in Wear Trial Product Testing and review with QA management
  • Ability to successfully implement quality plans for all phases of a trial
  • Ability to make and defend pragmatic quality decisions relating to the conduct of clinical trials
  • Develops, maintains, and improves an internal audit process to ensure compliance to relevant QMS standards, and to support organizational performance against the strategic direction and quality objective targets
  • Reviews new QMS standards and performs gap analysis between such standards and the current QMS
Qualifications for QA auditor
  • Strong Measurement Knowledge
  • Experience with Adobe Illustrator, Corel Draw, Adobe Photoshop, preferred
  • Ability to train co-workers on best work practices
  • Ability to travel 2-3 times per week to carry out above responsibilities
  • Flexibility to overseas
  • Knowledge of Warehouse Management Systems and general practices
4

QA Auditor Job Description

Job Description Example
Our growing company is searching for experienced candidates for the position of QA auditor. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for QA auditor
  • Ensures effective and timely corrective action from internal audit findings
  • Maintains and improves the internal corrective action reporting application
  • Prepares reports and presentations for top management on the organizational performance against quality objective targets related to internal audit and corrective action processes
  • Conducts supplier audits as needed to support risk assessments within engineering projects and/or subcontracted processes or products
  • Conducts supplier audits as needed to support quality engineering in supplier corrective action verification and/or improve supplier performance ratings
  • Builds an effective internal quality audit staff
  • Interfaces with QMS registrar auditors and other staff as needed during all phases of external QMS audits from planning stages to closure of associated corrective actions
  • Conducts appropriate data analysis and research to identify potential causes of customer complaints, and ensures effective and timely corrective action for customer complaints
  • Maintains and improves the Standard Operating Procedure (SOP) development and approval process, and other forms of communications related to work processes, methods, and standards of performance
  • Leads and/or participates in continuous improvement teams as organized by management
Qualifications for QA auditor
  • Ability to relate to all levels of management and associates
  • Equipment certified or ability to be trained as an Equipment Operator is mandatory
  • Complies with and promotes rules and policies in matters of the Group Code of Ethics and the American Society of Quality (ASQ) Code of Ethics, with particular emphasis in the areas of customer relations, supplier relations, employee relations, safe working environment, and product quality and safety
  • ASQ certified quality auditor or engineer required
  • Prior experience in managing an internal audit program and conducting internal audits, preferably in a manufacturing environment
  • Strong knowledge of lean Six Sigma manufacturing tools and statistics
5

QA Auditor Job Description

Job Description Example
Our company is hiring for a QA auditor. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for QA auditor
  • Provide proper training to improve investigations for determination of an effective action plan
  • Identifies and leads implementation of new opportunities for improvements to work processes, production, QA testing, and other areas as identified
  • Investigates product/component issues by conducting failure investigations, complaint trending, and Product Inquiries
  • Manage Health Hazard Evaluation process and assure timely completion
  • Manage Quality metrics meetings to provide proper corrective and preventive actions to address the identified issues
  • Supports Quality management, which includes ensuring that internal and supplier audits are properly executed, documented, and completed in accordance with the annual audit procedures/schedules
  • Verifies appropriate file documentation is included for completion of the review process
  • Monitors / analyzes performance trends for key quality metrics and establish appropriate control measures and communicates this to supervisors and management
  • Establishes, develops, enhances and maintains a QA methodology within the framework of estimate review
  • Formulates and maintains quality assurance objectives complementary to company policies and goals
Qualifications for QA auditor
  • Thorough knowledge of various quality system standards (e.g., ISO 9001)
  • A minimum of five years’ experience in quality assurance, quality engineering or related functions or a M.S
  • Prior experience in a FDA regulated industry or ISO certified organization
  • A Bachelors degree in Engineering, Science or related field is required
  • Must have demonstrated proficiency in statistical analysis, the ability to analyze and solve complex problems, and the ability to communicate effectively across departments
  • Working knowledge of quality systems is required

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