Business Analyst

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 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 Business Analyst will collaborate cross functionally with various areas of the organizations to develop a deep understanding of how our Laboratory Information Management System (LIMS) is enabling digital execution of Quality Labs sample management and data collection. The Business Analyst will solve business challenges and/or maximize opportunities, while understanding business needs, requirements, and current processes. The successful individual must have a combination of analytical skills, quality systems understanding, and business acumen with an ability to think enterprise wide.
Primary Responsibilities

• Quality Labs Expertise: Has a deep understanding of the lab processes such as sample management, test execution/documentation, results review, product release/metrics, and instrument data acquisition across multiple labs (Chemistry, Microbiology, Biology).
• LIMS Expertise: Utilize in-depth knowledge of LIMS modules such as, Electronic Laboratory Notebook (ELN), Environmental Monitoring (EM), Sample Management, Instrument Interface, Results Entry, Inventory Management, and Reporting tools to streamline laboratory processes, manage data, and ensure compliance with industry standards.
• Requirement Analysis and Management: Able to assess business needs, including the business case for system enhancement requests.
• Collaboration: Seek to understand the data and digital process needs of our stakeholders. Work closely with the lab managers, IT, Software Quality and Business Process Owners to manage the progress of system enhancement execution.
• Process Improvement: Identify opportunities for process improvement and automation within the laboratory, leveraging LIMS functionalities to enhance efficiency and accuracy.
• User Training: develop and deliver user training programs for laboratory staff to ensure they can effectively utilize the LIMS system, and provide ongoing support and troubleshooting.
• Change Management: Manage change control process relating to LIMS system changes, assess the impact of changes, and communicate effectively with stakeholders.
  Document technical design and requirement definition documents that will be used to implement system features and reports.
  Ability to learn and map lab processes and technology usage in different quality labs across the organization, documenting results in lab workflows.
  Evaluate and analyze moderately complex technical information and data related to quality indicators, identifying trends and driving factors and recommending course corrections. Draft presentations and present summaries of trends, potential root causes, and recommended course corrections
  SME point of contact for the local lab operations team, supporting resolution of processing bottlenecks
  Strong documentation skills.

Additional Responsibilities

• Performs other related duties and assignments as required

Qualifications

• 5+ years of related experience
• Experience in the medical device, pharma, biotech, or healthcare related industries
• Experience with electronic LIMS Systems (Labware, LabVantage, Agilent etc.)
• Knowledge and experience with Quality Systems
• Excellent written and verbal communication skills
• Results-oriented, positive "can-do" attitude with demonstration of appropriate urgency and initiative
• Detail-oriented, producing high quality work.
• Strong ability to manage and work with different cultures and nationalities.
• Ability to manage competing and evolving priorities in a fast-paced environment.
• Ability to adapt to new technologies and rapidly changing environment
• Participate in project communications, training materials, and business procedures/documentation.
• Ability to interface with multiple cross functional stakeholders.

Education & Certifications

• Bachelor's Degree in in 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:

• 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 65.00 - 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