Quality Assurance Senior Specialist Jobs in Cleveland, Arkansas

3+ years experience working with test management tools.

Experience with source control management and DevOps practices preferred.

Attend management meetings on behalf of team.

Manage the maintenance and execution of the automated test suites in support of frequent deployments

5+ years work experience in software testing and quality assurance

4+ years experience designing and developing automated tests in Selenium or equivalent tool(s)

Participate in product design review with product managers, software engineers, and other stakeholders to contribute to product design, testability, and implementation.

5 years of experience working in a complex, matrixed & dynamic organization.

4 years of experience in Software development, coding, developing test automation using Python, or Java or C#.

3 years of experience in building and scaling test automation for web based applications using Javascript or Typescript.

4 years of experience in developing test methodologies, writing test plans, creating test cases, and debugging.

Experience with at least one automated test framework like Cypress, Playwright, or Selenium Webdriver.

Excellent communication, analytical and time management skills. Must demonstrate ability and desire to continually learn.

Experience with test case management tools such as Azure DevOps, test case generation techniques, and problem tracking/reporting systems.

Experience with database management systems/SQL.

Experience developing UI and API automated tests

Experience testing web services that support protocols such as SOAP, REST and HTTP

Extensive experience with the creation/refinement of acceptance criteria

Mastery knowledge and expert experience with system development, data analysis, analytic application, reporting, administrative data sources, data use policies and procedures.

Mastery skills in analyzing healthcare service requirements and formulating policies. Ability to plan, organize, and implement independent projects concurrently.

Mastery knowledge of Quality Framework for long-term care programs.

Works with healthcare provider organizations and healthcare advocacy organizations on policy and programmatic changes.

Provides training and support to the Quality Improvement Strategy team on systems, policies, and procedures.

to support a local contract.

Experience with Quality Management Systems (e.g., documentation and record management, change control, deviations, investigations, training and CAPA programs)

Proactively report audit findings to management with recommendations for resolution and verify appropriate corrective actions have been implemented and documented.

Report and escalate compliance issues to management, including requests for directed audits and manage Quality Council Quarterly Meetings.

Lead, develop and manage R&D quality systems (procedures and processes) to provide compliance oversight, training and inspection readiness.

Train on QA overall, R&D SOPs, QA related regulatory intelligence and requirements, inspection readiness.

Manage QA reviews of project-related essential documents.

Knowledge of FDA QSR, relevant ISO guidelines and 21 CFR Part 11. Has knowledge of Design Control requirements.

Completes software quality tasks in accordance with current Quality System Requirements.

Works independently with objectives given by SWQA Manager.

Bachelor’s degree, or equivalent experience, in a scientific, technical, or engineering discipline.

5 to 8 years’ experience in Software Quality Assurance and/or Software Testing experience.

Must have excellent oral and written communication skills.

Background in Medical Device industry is highly desired.Pharmaceutical experience only would be acceptable.

Technical Writing (author SOPs & Work Instructions)

Medical Device (pharmaceutical is fine)

This person will assume a hands-on role and report into the IT Business Partner.

This Candidate must have a background in the following:

Experience with DevOps processes, typically using an Agile methodology

Experience in monitoring and interpreting real-time Application Insights results

Previous experience with Azure and Microsoft technologies that relate to QA, including Azure DevOps.

Experience with automated, manual, integration and end-to-end/system testing is required.

Strong knowledge of software quality assurance principles, methodologies, and processes.

Develop and implement a strategic and comprehensive QA program.

G. Three years of experience with Application Lifecycle Management, tracking bug fixes, test results, and release management.

*Candidates chosen for an interview will meet the Education, General Experience and Specialized Experience requirements.

A. Two years of experience with establishing and executing automated test procedures.

B. Three years of software testing experience (integration and acceptance) on multiple projects.

D. Three years of experience testing database interfaces in a multi release project environment.

A. Determine the resources required for quality control.

4-6 years of experience in the finance industry focusing on quality assurance for AML transaction monitoring, internal/external investigations, and KYC functions

Conduct quality assurance reviews on transaction monitoring and customer due diligence

Analyze completed cases to ensure that analysis is completed and all required and relevant documentation supporting each review is provided

Review cases related to the disposition of adverse media alerts to ascertain whether they are correctly determined

Collaborate with the AML Team to provide feedback as appropriate and ensure any corrective actions required are completed

Participate in the development and implementation of procedures and objectives for the QA function

Communicates confidently and effectively with management, peers, and key stakeholders.

Creates and reviews risk management documentation to reduce or eliminate risk.

Minimum 5 years In Quality or related field experience; Less experience may be appropriate with advanced degree.

Career development with an international company where you can grow the career you dream of.

Free medical coverage for employees* via the Health Investment Plan (HIP) PPO

An excellent retirement savings plan with high employer contribution

Responsible for activities involving quality assurance and compliance with applicable regulatory requirements

Requirements analysis, test case development and test execution for new software applications as well as application enhancements

3+ years of experience in Software Testing & Quality Assurance

Experience working with Microsoft TFS Required

Proficient experience with writing SQL queries and solutions

Tool experience for developing functional and performance automation validation

Tools used, SQL Server Management Studio, Javascript, HTML.

Shall test all software to ensure compliance with standards and requirements of our customers.

Masters’s degree in Computer Science/Engineering or foreign equivalent plus 12 months of work experience in the field.

The beneficiary shall create and maintain project test plans.

Review the test output and document results including logging and following up on identified problems.

The beneficiary will be responsible for analyzing and evaluating existing or proposed systems for our customers.

5+ years experience as QA Engineer or Test Automation Engineer

Excellent scripting skills in JavaScript

Experience using Selenium, JMeter, and Postman

Experience using and testing Single Page Applications

Experience using JIRA and TestRail

Experience with load and performance testing

Minimum of 5 years of experience in quality management

Prior experience in a quality management system within a manufacturing environment. Preferably ISO9001 and ISO13485

Ensures all sites meet quality management standards of ISO9001 and ISO13485. Manage site audits.

Must be able to work on multiple projects simultaneously and demonstrate organizational, prioritization, and time management proficiencies.

Prior experience in support internal and external audits

Knowledge of robotic liquid handling or comparable complex scientific lab equipment

Excellent problem-solving skills and experience with root cause investigations and CAPA determination

Knowledge of U.S. and international regulatory standards and guidelines

Strong computer skills including MS Office (Word, Excel)

Experience with rare diseases, neuromuscular diseases and/or gene therapy products

Experience in a small company and high growth, fast-paced environment

Perform review and approval of master production batch records.

Management of multiple quality system processes including, but not limited to, change control, deviation/CAPA management, and internal auditing.

Support and train on Quality Management Systems as needed.

Understand and comply with ethical, legal, and regulatory requirements applicable to our business.

5+ years of GMP quality experience in a biologic, Active Pharmaceutical Ingredient, or Drug Product manufacturing environment

Good working knowledge of associated industry and regulatory guidance documents; FDA guidelines, ICH Q7, 21 CFR Parts 210 and 211

Good working knowledge of cGMP and regulatory standards as they pertain to Drug Product and/ or API manufacturing.

Uses complete understanding and wide application of technical concepts, standards,and practices in chosen field and is expanding knowledge or related disciplines

Full knowledge of industry standards and Good Lab Practices

Applies analytical skills and independent judgment to develop innovative, practical, and consistent solutions to a wide range of complex problems

Working knowledge of U.S. and international regulations (QSR, ISO, GLP, cGMP)

Experience working under pressure, prioritizing, and multitasking quality issues in real-time

Excellent oral and written communication skills

Experience with us of ethylene oxide and at least one additional sterilization modality (e.g. radiation, moist heat, dry heat)

Good interpersonal and organizational skills.

Experience with GMP audits, internal and relevant external audits

Experience with overseeing biocompatibility studies

Work directly with the BWI R&D teams to validated and transfer break-through technologies to enable future growth and innovations.

Drive selection of sterilization modality, validation approaches and validation of the sterilization process for new products, and the sites for execution.

Timeline management and experience using internal and external resources to achieve objectives.

Experience in inspection readiness and management.

Develop and reports Key Performance Indicators to measure CMO and Labeler performance and for contribution to Management Review.

Analytical and problem-solving skills; experience in root cause analysis.

Develop and use Quality Agreements to manage vendor activities, outputs and records.

Solid experience working within US and EU GMPs.

Experience in in the areas of Clinical Quality Assurance, Supplier Quality Management, External Manufacturing Oversight, or Cell Therapy a plus!

Report quality system and supplier performance metrics to Quality Management Review.

Minimum 8+ years of relevant experience including pharmaceutical/biotechnology industry and Quality Assurance experience.

Excellent understanding of GxP requirements with focus on FDA and EMA

Excellent verbal and written communication skills

Generate and maintain Quality Assurance procedures and programs, ensuring alignment with FDA and EMA regulatory expectations.

At least 6 years of experience in a regulated manufacturing environment, preferably in biotechnology or pharmaceutical industry.

Advanced knowledge of cGMP regulations and FDA/EU guidance related to biologics or cell and gene therapies.

Demonstrated experience directly supervising employees.

A high degree of accuracy and attention to detail, and excellent interpersonal, oral and written communication skills.

Main responsibilities will include, but are not limited to:

Collaborate with business partners and provide meaningful guidance to help facilitate resolution of issues across organizational boundaries.

Manage at least one Quality Assurance (QA) test region so it’s always up-to-date with the latest code

5+ years of experience with both manual and automated testing tools such as Postman, Rest Assured, and Selenium

3+ years of experience in acceptance testing and regression testing for several applications

5+ years of experience with Unix - Shell scripts and PERL scripts

3+ years of experience with GIT

Bachelor's degree in computer science, engineering, or a related field or equivalent work experience

Strong knowledge of APM (Application Performance Management) tools & SDLC integration

Bachelor's Degree or equivalent combination of education and experience

ISTQB or other industry certification or equivalent work experience

Expert knowledge of the (SDLC) Software Development Lifecycle

Strong written and verbal communication skills

Knowledge of multiple load test tools and frameworks

6+ years of QA and Development experience • Having good knowledge of tools and technologies:

Knowledge/experience of testing multiple platforms, browsers, and mobile devices, using AWS testing tools

Review test cases and procedures to ensure coverage of and conformance to business requirements

Stay current with technology, tools and software quality assurance practices and share knowledge with others

Strong skill in Automation, Scripting (UNIX shell, SQL querying)

Strong understanding and experience in all QA activities in the SDLC

Preferred Education, Experience, & Skills

2 to 5 years of experience in software testing, with a focus on automated testing.

Strong knowledge of automated testing frameworks and tools, such as PyTest, Selenium, or similar.

Familiarity with agile development methodologies and experience working in an agile team.

Experience collaborating with cross-functional teams to understand user stories and acceptance criteria.

Knowledge of 508 compliance testing and accessibility standards.

Operate the ECO system within our electronic Quality Management System (eQMS)

Experience operating a change control system in a regulated environment (medical device, pharma, diagnostics) with five years of experience preferred

Strong verbal and written communication skills and interpersonal skills

Document Control including releasing approved documents and controlling revisions

Assisting other professionals with ECO creation

Routing ECOs and associated documents to the appropriate reviewers/approvers