IS Analyst Senior Associate

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

The IS Analyst Senior Associate will Integrate a variety of systems technologies to provide systems-related solutions to meet business needs. This role demands strong technical expertise to actively contribute to projects, as well as project planning and architecture.

Primary Responsibilities

• Supports the creation and maintenance of Benchtop Systems roadmap.

• Delegate to IT Application Owner of laboratory informatics systems across multiple labs.

• Delegate to Site DTI System Owner to manage Chromatography Data Systems (CDS), and Laboratory Method Execution System (LMES).

• Provide technical support for upgrades and enhancement projects.

• Work with clients and vendors to develop and translate functional requirements into design specifications.

• Develop and execute test protocols and procedures.

• Troubleshoot application issues, and execute change controls.

• Develop/Maintain disaster recovery (DR) plans and conduct DR exercises.

• Proactively engage with Quality and Laboratory teams to encourage the use of technology to maximize the efficiency, capacity, and reliability of operations.

• Ensures that benchtop systems are robust, reliable, and available to meet business demand.

• Ensures that systems are maintained in a compliant manner according to the DTI quality systems standards.

• Maintain lifecycle plan for Quality and Laboratory Systems.

Additional Responsibilities

• Perform IQ/OQ/PQ activities as required.

• Support regulatory inspections and internal audits as required.

Qualifications

• Strong technical skills in systems integration, laboratory informatics systems, Chromatography Data Systems (CDS), and Laboratory Method Execution Systems (LMES) are essential.

• Experience in project participation and project planning.

• Ability to provide technical support for upgrades, enhancements, and troubleshooting application issues.

• Experience working with clients and vendors to gather functional requirements and translate them into design specifications.

• Proficiency in developing and executing test protocols and procedures

Education & Certifications

• A Master's Degree in Manufacturing, Engineering, or Computer Science, or a Bachelor's Degree with 6 months of experience in Manufacturing, Engineering, or Computer Science, or an Associate's Degree with 2 years of experience in Manufacturing, Engineering, or Computer Science, or a High School diploma/GED with 4 years of experience in Manufacturing, Engineering, or Computer Science.

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.

Compensation

Salary/Hourly Rate Range (W2): USD 20.00 - 32.00

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

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