QA Auditor Job Description
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:
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:
Desired experience for QA auditor includes:
QA Auditor Examples
QA Auditor Job Description
- 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
- 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
QA Auditor Job Description
- 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)
- 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
QA Auditor Job Description
- 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
- 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
QA Auditor Job Description
- 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
- 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
QA Auditor Job Description
- 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
- 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