Published date Posted on Indeed on May 13, 2022 (14 d ago)

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 Life Sciences is seeking an experienced Technical Analyst that will support USDM clients on a variety of compliance initiatives. This includes gathering, understanding and documenting business objectives, specifications and requirements.

Primary Responsibilities


  • Responsible for providing tier 2 application support to assigned products (i.e., Veeva QualityDocs, QMS).

  • Support system releases and enhancements to existing applications by providing technical expertise.

  • Test fixes and perform post-resolution follow-ups to ensure problems have been adequately resolved.

  • Perform change management activities, and oversee documentation of configuration and design specifications.

  • Configure and manage integrations to Vault platform as needed.

  • Partner with IT Business Analyst to identify gaps between business needs and technical capabilities; work to find innovative solutions that meet business objectives.

  • Author and refine system support processes, flow diagrams, configurations, and interdependencies.

  • Ability to work with and manage multiple vendors and managed services providers.

  • Assess, provide application solutions and recommendations to all levels of management.

  • Participate in system validation activities and collaborate with team members on Validation Plans, User/Functional Requirements, Risk Assessments, Performance Qualification/UAT, Validation Summary Reports….etc.

  • Provide support and Subject Matter Expertise related to GxP Systems during internal audits or regulatory inspections.

Additional Responsibilities


  • Train others as appropriate on specific area of business or systems expertise.

Qualifications


  • 5+ years’ experience in applying information systems solutions to business problems.

  • 5 + years of experience with some experience with Life Science OR Pharmaceutical domain.

  • Experience gathering, documenting, communicating, and managing requirements through project lifecycle.

  • At least 3 years of direct experience with regulated systems and documentation.

  • Ability to work expeditiously in an ambiguous and aggressive schedule.

  • Ability to translate requirements from business processes.

  • Solid knowledge of the application development process.

  • Strong communication skills (verbal/written/listening).

  • Sense of urgency with strong follow-up skills.

  • Detailed oriented and able to work within a team setting.

Education & Certifications


  • Undergraduate degree, Master's degree preferred or relevant work experience in systems or business.

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.

  • Travel to client site for onsite work as needed.

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.


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