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Validation Tester (LIMS)

SPECTRAFORCE TECHNOLOGIES Inc.

This is a Full-time position in Richmond, VA posted February 5, 2021.

This is Amit with Spectraforce Technologies. Spectraforce Technologies is a certified MBE specializing in global contract staffing and payrolling. Spectraforce is an equal opportunity employer, which is a global staffing, consulting and technology solutions company, offering industry-specific solutions to our fortune 500 clients and worldwide corporations. We have an opening of Validation Tester (LIMS) for one of our clients in Richmond, VA. Job Description This role supports the development, implementation, improvement, andor effectiveness of Quality Systems in compliance with applicable company, laboratory, FDA, ISO, and other regulatory agency regulations, policies, and standards through implementation of effective software validation and change control processes. Completes Software Quality Assurance (SWQA) tasks in accordance with current Quality System Requirements. Works independently according to established objectives. Can plan and coordinate own work according to higher-level project schedules. Reviews pre-defined deliverablesactivities as identified in Non-Product Software (NPSW) quality processes andor Product software quality processesproject plans or equivalent project plan. Provides accuracy, clarity, consistency, completeness, and compliance for multiple projects. Deliverables include System SpecificationsRequirements documents, Verification Test Cases, VerificationValidation protocols, Trace Matrices, and VerificationValidation Summary Reports for assigned projects. Reports unexpected events, issues, or software bugs which occur during verificationvalidation to project team and management and according to established quality processes. Develops and maintains departmental operating procedures to ensure compliance to relevant FDA QSR, ISO guidelines, including 21 CFR Part 11 and Client Corporate requirements as they relate to the development, verification, validation, and maintenance of computerized systems used in the Quality System as well as those used in development of softwarefirmware products. May develop and maintain Validation Master Plan(s). Minimum Qualifications Bachelorrsquos degree, or equivalent experience, in a scientific, technical, or engineering discipline. 5 to 8 yearsrsquo experience in Software Quality Assurance. Knowledge of FDA QSR, relevant ISO guidelines and 21 CFR Part 11. Has knowledge of Design Control and software validation requirements. Must have 2 – 4 years project experience in software testing practices, methodologies, and techniques, preferably in regulated clinical laboratory or medical device or pharmaceutical testing laboratory operations. Industry experience in qualification of software systems according to accepted industry framework such as GAMP 5, ICH, or ASTM guidelines and principals. 2 ndash 4 yearrsquos experience in validation of chromatography data systems (CDS), Laboratory Information Management Systems (LIMS) or Laboratory Execution Systems (LES), andor computerized laboratory equipment such as (LCMS, GSMS, HPLC, etc.) and equipment software interfaces is required. Preferred Qualifications Experience with Cybersecurity and internet facing applications is highly desired. Experience performing software vendor qualification assessment and audit is a plus. Strong analytical, written, and verbal communication skills and the ability to articulate complex quality and regulatory matters with persons of a variety of backgrounds. ASTQB or similar certification in software quality assurance or software validation is beneficial. This is not necessarily an all-inclusive list of job-related responsibilities, duties, skills, efforts, requirements or working conditions. While this is intended to be an accurate reflection of the current job, SPECTRAFORCE and the assigned client reserve the right to revise the job or to require that other or different tasks be performed as assigned. Benefits SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, and hospital indemnity insurances. Additional benefits SPECTRAFORCE offers to the eligible employees include commuter benefits, 401K plan with matching and a referral bonus program. SPECTRAFORCE offers unpaid leave as well as paid sick leave when required by law. Equal Opportunity Employer SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at mailto if you require a reasonable accommodation For immediate consideration, please send resume to mailto OR Feel free to contact us at EXT-4 tel20EXT-4 316.

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