Quality/Deviation Investigator

About USDMUSDM 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 set 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 JobSeeking an experienced Quality Investigator to support deviation management originating from Manufacturing and Facilities departments. The ideal candidate brings hands-on GMP experience, strong investigative instincts, and the ability to drive investigations from initiation through closure with minimal oversight. Primary ResponsibilitiesInvestigate deviations generated by Manufacturing and Facilities departments, identifying root causes using structured methodologies (e.g., Fishbone, 5 Whys, Fault Tree Analysis) Develop well-supported Corrective and Preventative Action (CAPA) plans based on investigation findings Execute assigned CAPAs, including action tracking, documentation, and effectiveness verification Collaborate cross-functionally with Manufacturing, Facilities, and Quality teams to gather data and drive timely investigation closure Ensure all investigation documentation meets regulatory and site-specific quality standards Identify deviation trends and escalate systemic issues to Quality leadership as appropriate Additional Responsibilities Performs other related duties and assignments as required Qualifications3-6 years of experience in a GMP-regulated manufacturing environment (pharmaceutical, biotech, or related industry) Demonstrated experience performing root cause analysis and authoring deviation investigations Hands-on experience with CAPA development and execution Strong written and verbal communication skills with the ability to present findings clearly Ability to manage multiple investigations simultaneously with a high degree of independence Experience investigating deviations originating from Facilities or utility systems Proficiency with a Quality Management System (QMS) platform Working knowledge of FDA regulations (21 CFR Parts 210/211) and/or ICH guidelines Education & Certifications Bachelor's degree in Computer Science or Information Systems or related field. Master's Degree preferred Working ConditionsThe 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 StatementUSDM 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. DisclaimerThis 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. CompensationSalary/Hourly Rate Range (W2): USD 60.00 - 75.00 The base salary/hourly rate range represents the anticipated low and high end of the USDM's compensation range for this position. Actual salaries/hourly rates will vary and will be based on various factors, such as the candidate's qualifications, skills, competencies, and proficiency for the role. The compensation described above is subject to change and could be higher or lower than the range described based on market survey data or budget. Full-time employees are eligible for health, vision, and dental insurance, life insurance, short and long-term disability, hospital indemnity, accident, and critical care coverage. Both full and part-time employees, who are at least 21 years of age, are eligible to participate in USDM's 401k plan. Full and part-time employees may be eligible for paid time off. All employees are eligible for USDM's rewards and recognition program. For more details about our benefits, visit us here: