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 set us apart. From strategy to implementation and adoption, we have delivered thousands of GxP projects globally.
As part of the USDM team, you will 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 into a progressive, global company with 300+ remote employees and offices throughout the US, Canada, and Germany.
Nature and Scope of Job
USDM Life Sciences is seeking an IT Business Analyst to provide integration services between solution architects, the business, and project management while maintaining a deep understanding of the business from a technical lens and knowledge of schedule & resource allocation. This role ensures that business processes embedded across various businesses, functions, and regions are integrated, aligned, and capable of executing the strategy globally. This role is focused on process design and process integration from a technology standpoint.
Primary Responsibilities
- Execute project activities and author/produce System Development Life Cycle (SDLC) deliverables as defined in the Validation Plan or as outlined in the project Deliverables List, applicable BD methodologies, standards, and Good Documentation Practices (GxP).
- Provides input to the requirements, risk assessments, system design, testing approach, traceability, and other documentation.
- Develop/author Regulatory Impact Assessment, User Requirements Specification, Functional Requirements Specification, and Traceability Matrix.
- Contribute to the development of various assessments and plans, including regulatory, security, privacy, audit, design, risk, validation, system design, testing, data migration, periodic review, decommissioning reports, and more.
Additional Responsibilities
- Collaborate with other project team members including Business Partners, Project Manager, Technical Lead, Technical SMEs, Business SMEs, Test Lead, Testers, and Validation Lead.
- Support the client with various tasks as assigned.
Qualifications
- Experience in producing quality deliverables per System Development Life Cycle (SDLC) methodology.
- Experience working in GxP-regulated Computer Systems Validation (CSV) including 21 CFR Part 11 is required.
- Experience/domain expertise in the Life Sciences / Medical Device industry is required.
- Experience working in Product Lifecycle Management (PLM) implementation, upgrade, and migration programs/projects is required.
- Functional knowledge of foundational PLM capabilities like Part/CAD/BOM Management, Document Management, Design Control (DHFs/DMRs), Requirements and Risk Management, Configuration/Variant Management, and Change Management is required.
- Experience in Siemens Teamcenter is preferred.
- Experience working in Application Lifecycle Management (ALM) implementation projects and tools like Siemens Polarion is preferred.
Education & Certification
- Bachelor's degree in Engineering, Life Sciences, Information Technology or a related field.
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:
- Sit or stand at a desk in an environmentally controlled office environment for prolonged periods of time.
- Constantly operate a computer and 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.
Compensation
Salary/Hourly Rate Range (W2): USD 60.00 - 80.00
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: https://usdm.com/careers