Job Description
Job Summary
The EBA Computer Software Validation Specialist is the technical quality contact on a project and oversees the quality related to project deliverables. The EBA Computer Software Validation Specialist provides guidance on key validation activities as defined in the Validation Plan, such as supplier audits, qualification plans/reports, change control records and configuration management.
Job Duties
• Reviews & proofreads project documentation including User Requirement Specification and Design Specification
• Works with internal and external teams to ensure that tests are carried out successfully
• Develops and maintains verification and validation plans, protocols, and associated reports
• Reviews and approves test scripts
• Reviews and approves test executions to verify objective evidence is attached and verifies the expected results have been achieved
• Ensures defects are raised, resolved, and closed as needed
• Develops and maintains requirement traceability matrix (RTM)
• Monitors the progress of the project through to closure and provide GxP and regulatory input into validation projects
• Documents and manages deviation reports
• Documents and manages Corrective Action and Preventive Action (CAPA) initiatives
• Develops and keeps up to date supporting documentation for product QA
• Participates in team and project meetings
• Performs any other related duties as required or assigned
Education
Qualifications, Knowledge, Skills, and Abilities:
• High School Diploma or equivalent GED, required
• Bachelor’s degree, preferred
Experience
• Four (4) or more years in Quality Assurance, required
• Three (3) or more years in computer system validation in regulated environment, required
• One (1) or more years working with regulatory requirements, including GAMP5, Part 11, and ability to implement the V-model (GAMP) and as it pertains to computerized systems, required
Software
• Experience with NetSuite, required
• Experience with ERP systems, preferred
Other Knowledge, Skills, & Abilities
• Good understanding of electronic records and electronic signatures requirements (FDA, Annex 11)
• Strong understanding of testing methodology and the software development lifecycle (SDLC)
• Able to develop and learn new and emerging technologies
• Solid understanding of object-oriented programming (OOP)
• Strong written and verbal communication skills
• Must be open to travel to client sites, if needed
Keywords: Software Validation, CSV, Quality Assurance, Regulatory, GAMP, GAMP5, SDLC, ERP NetSuite
Individual salaries that are offered to a candidate are determined after consideration of numerous factors including but not limited to the candidate’s qualifications, experience, skills, and geography.
California Range: $108,000 - $137,000
Colorado Range: $108,000 - $137,000
New York City/ Valhalla Range: $108,000 - $137,000
Washington Range: $108,000 - $137,000
About Us
BDO delivers assurance, tax, digital technology solutions and financial advisory services to clients throughout the country and around the globe. We offer numerous industry-specific practices, world-class resources, and an unparalleled commitment to meeting our clients’ needs. We currently serve more than 400 publicly traded domestic and international clients.
• Unparalleled partner-involvement
• Deep industry knowledge and participation
• Geographic coverage across the U.S.
• Cohesive global network
• Focused capabilities across disciplines
BDO brings world-class resources and exceptional service to each and every one of our clients. BDO USA is a member of BDO International, the world’s fifth largest accounting network.
BDO offers a competitive Total Rewards package that encompass so much more than – “traditional benefits”. Our wide range of rewards and our employees’ ability to customize rewards to their individual needs are two of the reasons why BDO has been honored with so many workplace awards, including 100 Best Companies for Working Parents, Working Mother 100 Best Companies, Top Entry Level Employer, 2022 National Best & Brightest Companies to Work For and more.
Some Examples Of Our Total Rewards Offerings Include
• Competitive pay and eligibility for an annual performance bonus.
• A 401k plan plus an employer match
• Comprehensive, medical, dental, vision, FSA, and prescription insurance from day one
• Competitive Paid Time Off with daily accrual from day one of employment, plus paid holidays
• Paid Parental Leave
• Adoption Assistance
• Firm paid life insurance
• Wellness programs
• Additional offerings include BDO Flex, Group Legal insurance, Pet insurance and Long-Term Care Insurance
Above offerings may be subject to eligibility requirements.
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All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability or protected veteran status.
"BDO USA, P.A. is an EO employer M/F/Veteran/Disability
