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 is looking for a strong QA Specialist/Reviewer who will support our clients on a variety of compliance initiatives.

Primary Responsibilities

• Review/comment, creation, amendment, approval/rejection of change control requests.
• Review/comment of CSV strategies and deliverables, and of periodic review summary reports.
• Active participation, review/comment, and support in the processing of quality records (e.g., Deviations and CAPAs) for GxP systems, throughout their entire lifecycle.
• Active participation in system/requirements/specification risk assessment sessions.
• Active participation in Review/comment, and assessment of (SaaS) release notes to define testing coverage and level of testing rigor.
• Evaluation of project timelines to correctly ascertain proper time/resource estimates.
• Support weekly/monthly/quarterly performance metrics reportable to Sr. Leadership, as needed.

Qualifications

Three years of demonstrable, practical experience in the following areas:

• Providing QA specialist/review support and oversight of Computerized Systems Validation (CSV) activities related to initial implementation, change control, and decommission of GxP (i.e., GCP, GPV, and GMP) systems such as: Argus, LIMS, LMS, AE/PC/MI Intake, Veeva Vaults (e.g., QualityDocs, and QMS), ServiceNow, SAS, SFTP, TraceLink, REMS, ERP, SharePoint, and NonMem.
• Providing QA specialist/review support and oversight of CSV and Contract Service Provider (CSP) activities related to GxP systems deployed as SaaS by their original development organizations, as well as those hosted by another 3rd party CSPs.
• GAMP-based risk assessment and risk management approach.
• 21 CFR Parts 11 & 820, and Annex 11 regulations; and GAMP 5 best practices.
• Data integrity, periodic review, configuration management, software development & CSV lifecycles, Agile/Scrum and Waterfall development approaches.
• Authoring/co-authoring of Policies, SOPs, WIs, templates, Job Aids, and/or Best Practices.
• Use of electronic systems supporting CSV activities (e.g., MicroFocus ALM and ValGenesis).

Preferred Qualifications:

• Understanding of Computer Software Assurance (CSA) concepts (e.g., risk-based documentation, and leveraging testing from “lower environments” and/or from CSPs).
• Understanding of various software testing techniques (e.g., static, and dynamic testing).
• Experience with the validation of ERP and LIMS software products.

Education & Certifications

• University certificate or degree with a minimum of 5 years of related industry exp, or BS in Technology & 2-3 years of exp.

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.