About USDM

USDM Life Sciences is a premier consulting company with 20+ years of experience assisting heavily regulated biotech, medical device, and pharmaceutical companies with their GxP technologies to accelerate growth. Our deep domain knowledge and technology expertise in life sciences business processes are what sets us apart. From strategy to implementation and adoption, we have delivered thousands of GxP projects globally.

As part of the USDM team, you have the opportunity to work with cutting edge technologies through our many partnerships with companies like Microsoft, Google, Oracle, DocuSign, Box, and many more. From molecule to market, you will help connect technology, people, and data in new ways to generate real-time insights to improve business outcomes for USDM’s clients. Are you ready to make an impact and drive real digital transformation in life sciences?

Founded in Santa Barbara in 1999, USDM has grown to a progressive, global company with 300+ remote employees and offices throughout the US, Canada, and Germany.

Nature and Scope of Job

USDM is looking for an experienced CSV consultant that has knowledge/understanding of Audit Trail review.

Primary Responsibilities

• Ensure compliance with GxP regulations and industry best practices related to data integrity, by reviewing audit trails generated by computerized systems used in pharmaceutical manufacturing, laboratory testing, clinical trials, and other regulated activities.
• Implement procedural control for audit trail review program which includes but not limited to governing SOP, Audit trail review form, Frequency determination form, system specific SOPS.
• Conduct outine reviews of computerized system audit trails for GxP-regulated activities, to ensure completeness, accuracy, and integrity of data.
• Review electronic records and signatures for compliance with regulatory requirements, internal policies, and procedures.
• Identify potential data integrity issues or violations and initiating investigations as required.
• Collaborate with stakeholders to ensure timely resolution of identified issues and implementation of corrective and preventive actions.
• Maintain accurate and complete documentation of audit trail reviews, investigations, and related activities, in accordance with regulatory requirements and internal procedures.
• Keep up-to-date with the latest regulatory and industry developments related to data integrity and audit trail review, and contributing to the development and implementation of policies and procedures as required.
• Provide training and guidance to personnel on audit trail review and data integrity-related topics.

Additional Responsibilities

• Performs other related duties and assignments as required.

Qualifications

• Strong understanding of GxP regulations, computerized system validation, data integrity, and audit trail review best practices.
• Strong analytical skills, attention to detail, and the ability to work effectively both independently and as part of a team.
• Strong communication and interpersonal skills, as the role involves working closely with personnel across different departments and functions.

Education & Certifications

• University certificate or degree with a minimum of 5 years of related industry experience.

Working Conditions

The working conditions described here are representative of those that must be met by an employee to successfully perform the essential responsibilities and functions of the job, and are not meant to be all inclusive. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential responsibilities and functions of the job.

Unless reasonable accommodations can be made, while performing this job the staff member shall:

• Prolonged periods of sitting or standing at a desk and working on a computer in an environmentally controlled home office environment.
• Operate other office productivity machinery, such as a calculator, scanner, or printer.
• Frequently communicate with stakeholders via telephone, email, or instant message. Must be able to exchange accurate information in these situations.

Equal Opportunity Statement

USDM Life Sciences is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Disclaimer

This job description is intended to describe the general nature and the level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. USDM Life Sciences reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.