Published date Posted on Indeed on Nov 23, 2021 (7 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 IT QA Lead for our biotechnology client.

Primary Responsibilities

  • Approve system life cycle deliverables and activities to ensure that regulations, protocols, procedures, and methodologies are followed, and that appropriate and complete documentation is captured and reported to support validation activities.
  • Represent IT Quality & Regulatory Compliance on cross-functional teams in support of SDLC activities.
  • Consult on the authoring and conformance of validation-related deliverables and activities in regard to corporate SOPs and current regulations.
  • Provide guidance, training, and support to IT personnel in their validation efforts, to ensure compliance.
  • Provide quality assurance oversight for system related issues (deviations, incidents, etc.)
  • Assist in the development of IT Controls templates (SDLC deliverables, System Assessments, etc.)
  • Advise technical personnel and management on regulatory compliance and interpretation and recommend appropriate corrective actions where needed.

Qualifications
  • Thorough knowledge of GxP and ERES (21 CFR Part 11 and Annex 11) regulations and guidelines
  • Thorough knowledge of IT Controls methodologies, including GAMP5 and ITIL
  • Excellent communication skills, both verbal and written
  • Detailed knowledge of the general computerized system development life cycle in a regulated environment and software quality assurance
  • Knowledge of general software and database concepts
  • Experience with risk analysis and risk management practices and tools
  • Knowledge of infrastructure technology and platforms
  • The ability to work both independently and with teams at various levels in the organization
  • Excellent organizational skills and attention to detail and accuracy
  • Five or more years of experience in computerized system validation within a regulated environment

Education & Certifications

  • University certificate or degree with a minimum of 5 years of related industry exp

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.


Let us know

Help us maintain the quality of jobs posted on RemoteTechJobs and let us know if:

Loading...
Success
Error on reporting

Related jobs

At Ascensus, technology is more than just a solution. It powers the business that helps millions of people save for what matters—retirement, education, and healthcare. Our technology experts tackle exciting challenges in collaborative teams, but work in an environment where

Highbrow-Tech Highbrow-Tech |
Today

Job Responsibilities:Perform Development work (Design, Coding, Unit Testing and Support) in the Project. Lead assigned Modules, if needed.Responsible and accountable for the quality and cohesion of solution architecture components within the PBM and application, along with their.

Quality Assurance API ConsultantRemote, USA. 3 month contract with possible extension into 2023.Requirements:3+ years of experience as a QA Tester in a manual testing role2+ years of experience as a software developer or QA engineer, with experience understanding, writing, and te

Jonas Software Jonas Software |
2 d ago

Job Description:Job DescriptionAt Jonas C&R Software Professional Services, we are responsible for delivering C&R Software’s state of the art applications into an enviable client portfolio which includes many of the world’s leading financial institutions. Our

Connection has a fantastic opportunity through our Technical Staffing division for a Power BI Developer. This is a contract for a terrific end-client. This position is remote position.We at Connection offer terrific benefit options for our W2 contractors that start on the first d

Imagine a workplace that encourages you to interpret, innovate and inspire. Our employees do just that by helping healthcare payers manage the cost of care, improve competitiveness and inspire positive change. You can be part of an established company with a 40-year legacy that h

More jobs by this company

About USDMUSDM 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

USDM Life Sciences USDM Life Sciences |
19 d ago

About USDMUSDM 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

About USDMUSDM 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