Senior Quality Assurance Associate Jobs in Union, Arkansas

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

Support the execution and implementation of a Corporate Quality Management System (QMS) software.

5+ years of Quality Assurance experience in Pharmaceuticals, Compounding and Warehouse activities.

Quality Assurance certifications are a plus.

Excellent cross-functional collaboration, communication, and interpersonal skills.

Utilize the Quality GAP analysis to implement short and long-term Quality goals and objectives.

Determine, develop and train employees on appropriate inspection points at the warehouse using AQL inspection method techniques.

Bachelor’s degree preferred (or equivalent knowledge/experience)

Serve as QA review for contractor qualification assessment.

Minimum of 5 years’ experience in clinical research.

Certification in clinical research or regulatory affairs preferred.

Experience as a QA Associate/Clinical Quality Auditor or in compliance/utilization review preferred.

Strong working knowledge of FDA-regulated research, ICH Guidelines and GCP.

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.

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.

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)

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.

• 2+ years of people management experience (required).

• 5+ years of experience working with quality management system (desired).

The Senior Quality Assurance Manager will:

• Bachelors Degree with relevant fields with 4+ years of medical device industry experience.

• A competitive salary and stock option plan along with a range of benefits

• opportunities for continuing education.

• May work with management to update job training matrix.

• May track and report deviation QC trends to management.

• Coordinates and schedules all assigned quality control projects with minor assistance from coworkers and manager.

• Participates in continuing education through self-study, attending training sessions and lectures and meetings.

• Supports safety, quality, and 5S requirements and initiatives.

• Complies with company's procedures and regulatory requirements, as applicable.

Provide knowledge regarding QA concepts, methodology, best practices, tools and metrics.

Write, manage, and continuously re-evaluate test plans to adjust for new information and project schedules.

Assess projects to identify QA requirements and identify areas for improvement.

Excellent critical thinking and problem-solving abilities.

College Degree or equivalent experience required.

Experience testing ecommerce websites, responsive designs and mobile applications.

Monitor routine manufacturing operations for conformance to applicable procedures (see Gowning Qualification requirements below)

Sample and perform visual inspection of final products and raw materials. Perform other testing under the direction of QA Operations Manager

Transfer materials between facilities (see lifting requirements below)

Required experience in GMP and FDA regulated environments (ISO 13485:2016preferred)

1 year experience in regulated industry highly desirable

Perform line clearance activities and in-process inspections

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

Work with Department management to assign personnel and training materials to the appropriate Job Roles/curricula in Veeva

Interact with internal customers at various management levels to provide customer service

Manage GXP central filing system

Support Quality Control data entry processes

Minimum of 1-3 years of experience in a pharmaceutical and/or biotech company.

Advanced computer capabilities including all MS Office products

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