Quality Assurance Auditor
Location: Austin, Texas, United States
Requisition Number: 2677
Position Title: Quality Assurance Auditor
SUMMARY: To have experience and working knowledge in appropriate GxP compliance and other applicable regulations in order to conduct various types of audits to assess Worldwide Clinical Trials (WORLDWIDE) processes and procedures, applicable regulations and Sponsor SOPs, when necessary, with minimal supervision. Provides guidance on regulatory compliance to internal clients. The Quality Assurance Auditor works under the general supervision and guidance of the Manager, QA, Sr. Manager, QA, Director QA or Sr. Director, QA.
Tasks may include but are not limited to:
- Always representing WORLDWIDE in a professional manner (verbal, written, and in appearance) when interacting with sponsors, volunteers, outside vendors, and fellow employees.
- Works with QA team to plan, conduct and complete written reports for each audit assigned.
- Monitors the projects and audit status in assigned areas and provides QA Management with current status upon request.
- Fosters a good working relationship with internal clients and QA team.
- Identifies areas for process improvement and provides this information to management.
- Assists with corrective and preventive action plans (CAPAs) to assure follow-up and implementation of corrections for internal and external audits.
- Provides advice and guidance on regulatory requirements and SOPs.
- Assists with training and mentoring of less experienced auditors.
- Oversees the maintenance of records for each audit.
- Performs Vendor audits as required.
- Assists with creating and presenting GCP/GLP and other related training sessions.
- Minimal travel may be required.
Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.
OTHER SKILLS AND ABILITIES:
- Sound knowledge of applicable GxP regulations and requirements as well as WORLDWIDE policies and procedures.
- Ability to coordinate multiple projects and have the flexibility needed to adjust to changing priorities and unforeseen events.
- Ability to use logical inferences to understand the “big picture” and long-term implications of these issues.
- Ability to interact professionally and to work independently or in team.
- Excellent oral and written skills.
- Ability to prioritize work and define steps needed to achieve assigned project goals.
- Ability so speak, read and write English fluently.
- Experience with Microsoft Word applications and the ability to learn internal computer systems as necessary.
- Bachelor’s degree preferably in life science or equivalent experience gained by working in a relevant area (clinical setting, laboratory, etc.).
- Minimum 3 years’ experience in regulatory affairs, auditing, clinical research, monitoring, laboratory, or other relevant area required, of which, 1-2 are in quality assurance auditing.
- Other: Possible mental demands include, but are not limited to client contact, intense concentration, verbal communication, written communication, reading, math, and attention to detail, multiple tasks, frequent interruptions, and fluctuation in workload that is sometimes extremely demanding.
- Possible physical demands include, but are not limited to: lifting and carrying of objects weighing 5-60 lbs., hearing, seeing, gross and fine motor use of upper extremities, kneeling, walking, standing, leaning over for extended periods of time, squatting, eye strain/fatigue, climbing, pushing, pulling, reaching, and exposure risk to potentially infectious blood and/or body fluids, and/or hazardous fumes or chemicals.
Employment Type: Regular
Community / Marketing Title: Quality Assurance Auditor
We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.
Location_formattedLocationLong: Austin, Texas US
CountryEEOText_Description: Worldwide Clinical Trials is an equal opportunity employer, dedicated to a policy of non-discrimination in employment on any basis including age, sex, color, race, creed, national origin, religion, marital status, sexual orientation, political belief or disability.