Clinical Auditing Specialist II - Vendor and Information System Audits

Thermo Fisher Scientific • Wilmington, NC

23d

About The Position

Join us as Quality Assurance Auditor II (Internal Information System Audits Team) and enhance our clinical auditing processes by ensuring regulatory compliance and quality standards. What You’ll Do:
Conduct and/or lead internal information systems audits as requested by senior management including but not limited to computerized systems used in clinical trials, data integrity and security of internal facility systems and instrumentation, computerized system lifecycle management processes, and study build configuration user acceptance testing.
Provide GxP consultation and support to project teams and internal clients regarding information systems compliance including but not limited to 21 CFR Part 11 and EMA guideline on computerized systems used in clinical trials.
Serve as a knowledgeable resource to operational departments on audit or quality assurance subject matter
Prepare and present audit findings and/or other related information at departmental and internal operations meetings

Requirements

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• Previous QA experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years’). In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
• Thorough knowledge of GxP and appropriate regional research regulations and guidelines
• Demonstrated proficiency and led a range of GxP audits to high standards required by management
• Working knowledge or familiarity with GAMP 5 R2, computer system validation concepts, and the software development lifecycle (SDLC).
• Excellent oral and written communication skills
• Strong problem solving, risk assessment and impact analysis abilities
• Solid experience in root cause analysis
• Above average negotiation and conflict management skills
• Flexible and able to multi-task and prioritize competing demands/work load
• Valid driver's license and ability to qualify for and maintain a corporate credit card with sufficient credit line for business travel
• Ability to work in an upright and /or stationary position for 6-8 hours per day.
• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
• Frequent mobility required.
• Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.
• Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
• Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
• Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
• Frequently interacts with others to obtain or relate information to diverse groups.
• Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.
• Regular and consistent attendance.

Responsibilities

• Conduct and/or lead internal information systems audits as requested by senior management including but not limited to computerized systems used in clinical trials, data integrity and security of internal facility systems and instrumentation, computerized system lifecycle management processes, and study build configuration user acceptance testing.
• Provide GxP consultation and support to project teams and internal clients regarding information systems compliance including but not limited to 21 CFR Part 11 and EMA guideline on computerized systems used in clinical trials.
• Serve as a knowledgeable resource to operational departments on audit or quality assurance subject matter
• Prepare and present audit findings and/or other related information at departmental and internal operations meetings

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees