Quality Associate Auditor

Requisition Number: 6035

Position Title: Associate Auditor, Quality Assurance

External Description:

We’re a global, midsize CRO that pushes boundaries, innovates, and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence. 

We are Worldwide Clinical Trials, and we are a global team of almost 2,500 experts, bright thinkers, dreamers, and doers, and, together, we are changing the way the world experiences CROs – in the best possible way. 

Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.   

Summary: To gain experience and working knowledge in appropriate GxP compliance and other applicable regulations to conduct various types of audits and to assess Worldwide processes and procedures, applicable regulations, and Sponsor SOPs, when necessary.  The Associate Quality Assurance Auditor works under the general supervision and guidance of the QA Manager and Director of Quality Assurance.

Responsibilities:

Tasks may include but are not limited to:

• Always representing Worldwide in a professional manner (verbal, written, and in appearance) and maintains good working relationships when interacting with internal clients and QA team.
• Assists the QA team with other auditors 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 status upon request.
• Assist QA management with the revisions of applicable SOPs and quality documents.
• Assist QA management during sponsor audits and regulatory inspections.
• Assists with creating and presenting GxP and other related training sessions.
• Assists with corrective and preventive action plans (CAPAs) to assure follow-up and implementation of corrections for internal and external audits.

 Skills & Abilities:

• Develops and maintains knowledge of applicable GxP requirements
• Develops and maintains knowledge of Worldwide's policies and procedures
• Ability to interact professionally and to work independently or in teams.
• Excellent oral and written skills.
• Ability to prioritize work and define steps needed to achieve assigned project goals.
• Ability to speak, read and write English fluently.
• Experience with Microsoft Word, excel, PowerPoint applications and the ability to learn internal computer systems as necessary.

Requirements:

Bachelor’s degree preferably in life sciences or equivalent degree with experience gained by working in a relevant area (clinical setting, laboratory, etc.).

Preferred: 0-2 years experience in auditing, laboratory, clinical research, regulatory affairs, monitoring, or another relevant area.

Other: Possible mental demands include, but are not limited to client contact, intense concentration, verbal communication, written communication, reading, math, 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 objects weighing 5-50 lbs., sitting for extended periods of time, eye strain/fatigue, exposure risk to potentially infectious blood and/or body fluids, and/or hazardous fumes or chemicals.

City:

State:

Employment Type: Regular

Community / Marketing Title: Quality Associate Auditor

Company Profile:

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 is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law. Worldwide is committed to working with and providing reasonable accommodations to applicants with disabilities. We are proud to be an equal opportunity workplace where people thrive by being themselves and are inspired to do their best work every day.