QUALITY ASSURANCE AUDITOR SKILLS, EXPERIENCE, AND JOB REQUIREMENTS
Updated: Sep 19, 2024 - The Quality Assurance Auditor with substantial experience in construction quality management for large-scale projects is essential. This role requires familiarity with Mechanical, Electrical, or Instrumentation systems, and an understanding of both Australian and international standards. The ideal candidate should excel in multitasking, possess excellent communication, relationship-building, and problem-solving skills, and be proficient in key office software.
Summary of Quality Assurance Auditor Knowledge and Qualifications on Resume
1. BS in Quality Assurance with 2 years of Experience
- Quality and/or quality systems certification (e.g. ASQ Auditor, auditor training), or equivalent
- Experience in areas of Quality Assurance, Auditing, Validation, and/or SDLC systems in regulated industries in Pharmaceutical, CRO, Biotech, Medical device
- Demonstrated ability and track-record for leadership activities, supporting or mentoring personnel.
- Possesses a strong working knowledge of Good Clinical Practices (GCP), ICH Guidelines, Software Validation requirements and is competent with quality management systems (QMS)
- Knowledgeable of 21 CFR Part 11, Annex 11, and other applicable ERES regulations
- Computer literate and familiar with most common software applications (i.e., Word, Excel etc.)
- Understanding of medical and/or clinical trial terminology is desirable
- Ability to work independently and/or across cross-functional teams, ability to adjust to changing priorities
- Demonstrated ability to interact professionally and with confidence at all levels of internal and external personnel
- Excellent attention to detail and orientation toward meticulous work
- Strong interpersonal and communication skills, both verbal and written
- Strong documentation and organizational skills
2. BA in Business Administration with 3 years of Experience
- Relevant construction quality management experience on large projects essential
- Experience in Mechanical, Electrical or Instrumentation systems desirable
- Knowledge of completions database/system desirable
- Awareness of relevant Australian and International standards, both technical and those related to management systems
- Good communication, consultation, negotiation and influencing skills
- Solid relationship-building skills
- High-level writing skills and attention to detail
- Good presentation skills with ability to demonstrate and train others
- Ability to manage multiple tasks effectively & efficiently
- Proficient at problem-solving
- Ability to project and maintain a professional and positive attitude
- Possess high-level ethics and integrity
- Proficient in computer skills including Microsoft Word, PowerPoint, Outlook, and Excel.
- Demonstrated ability to adapt to shifting priorities, resourceful and strong problem-solving mindset
- Flexible and available to work outside of scheduled hours
3. BA in Management Information Systems with 4 years of Experience
- Experience in GMP Audits of API suppliers and TPMs.
- Knowledge and understanding of the ICH and other relevant technical guidelines, as well as GMP guidelines.
- Understanding of the WHO and other applicable regional and local regulations.
- Excellent communication skills.
- Proactivity and ability to work in a multi-cultural environment, with challenging deadlines.
- Advanced written and verbal skills in Business English.
- Competencies required such as adaptability, initiative, integrity, planning & organizing, information gathering, analytical thinking, interpersonal understanding, cultural sensitivity, ethical behavior, independence, decisiveness.
- Mechanic's Certificate with Airframe and Powerplant (A&P) ratings preferred
- Experience in aviation industry, CASS, Maintenance, Quality Control, and/or Quality Assurance preferred
- Excellent writing and communication skills in a professional demeanor
- Must possess integrity, honesty, and strong work ethic
- Eagerness to learn and willingness to contribute to the role
- Domestic and international travel may be required.