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 a Data Integrity Consultant.

Primary Responsibilities

Perform "Data Integrity" related- risk assessments, deviation investigations, suggest, implement remediations in cGMP operations.
Able to perform Data Integrity compliance/impact assessments, risk assessments and create short executive summary reports.
Perform data analysis, identify trends and prepare metrics.

Qualifications

Data analysis, identifying trends and preparing metrics.
Excellent presentation skills. (A good storyteller).
Strong critical, analytical/ logical thinking skills.
Familiar with using Office 365 suite of applications. (Power Point, Excel, etc.).
3-5 years of experience applying global data integrity regulations to cGMP operations, computer system validation, pharmaceutical manufacturing, lab testing, supply chain process, and quality management systems.
3-5 years of experience with Data Integrity risk assessments and process improvements in GxP operations.

Education & Certification Requirements

Undergraduate degree, Master's degree preferred or relevant work experience in systems or business.
5+ years' experience in applying information systems solutions to business problems.
5 + years of experience with some experience with Life Science OR Pharmaceutical domain.

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.

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.

Summary
Company name: USDM Life Sciences
Remote job title: Data Integrity Consultant