5,210 Pharmaceutical Quality jobs in the United States

As a global leader in ever expanding power and energy industry, we are looking for a skilled and motivated Software Developer to join our growing team. This role is focused on creating solutions that drive efficiency and innovation in our engineering and design processes.

Role Overview

The QA Analyst will play a critical role in ensuring software quality and business alignment by developing, implementing, and executing comprehensive test strategies—with an emphasis on User Acceptance Testing (UAT) and a variety of test platforms. The ideal candidate will thrive in Agile environments, collaborate across teams, and support the entire software development lifecycle through to production release.

Responsibilities
• Test Planning & Strategy - Develop, review, and implement detailed test plans and strategies mapped to business requirements, user stories, and acceptance criteria. - Design UAT processes in close collaboration with business stakeholders, ensuring user needs and business goals are fully validated before software release.

• UAT Management - Coordinate with business users and product owners to define, organize, and execute UAT cycles. - Drive creation and maintenance of UAT test cases, identifying necessary test data, and ensuring alignment with acceptance criteria. - Facilitate UAT sign-off, capture user feedback, and ensure all defects or issues are logged, tracked, and resolved before production deployment.

• Test Execution & Automation - Execute functional, integration, regression, Performance, and exploratory testing across multiple test environments (Dev, QA, Stage, UAT). - Utilize relevant test platforms, such as Jira, Azure DevOps, and HP Quality Center, for managing test cases, defect tracking, and traceability. - Prioritize and automate high-value test cases, working with CI/CD pipelines where appropriate.

• Database Testing: Perform backend testing using SQL and Oracle to validate data accuracy, integrity, and consistency across systems. Write and execute complex queries to verify business logic, data transformations, and stored procedures. Validate data migration and ensure referential integrity across environments.

• Defect Management - Identify, log, track, and retest defects found during all phases of testing. - Prepare and distribute test summary reports, including defect logs and closure status.

• Collaboration & Continuous Improvement - Partner with product owners, business analysts, developers, and release managers, ensuring clear user story and acceptance criteria definition. - Participate in Agile ceremonies—sprint planning, stand-ups, demos, retrospectives—offering feedback and suggesting quality improvements. - Support root cause analysis and postmortem for defects found in production environments.

This position offers the flexibility of a hybrid schedule

Qualifications
• 3+ years proven experience in software QA, including hands-on experience developing and executing UAT cycles and working with various test platforms.

• Solid understanding of Agile methodologies (Scrum, Kanban) and test management tools (e.g., Jira, Azure DevOps, HP Quality Center).

• Proficiency in SQL for validating data

• Experience in Automation tools –Selenium, Test Sigma, Test Rigor, TestIM, QTP, Postman, SOAPUI, JMeter, Load Runner

• Comfortable writing clear, traceable test cases, mapping them to user stories, and updating them throughout the project lifecycle.

• Demonstrated ability to coordinate and facilitate UAT with internal users and business stakeholders, ensuring thorough documentation and sign-off.

• Familiarity with test automation principles and CI/CD processes. Ability to write/Develop scripts to automate test cases and build test frameworks.

• Experience with defect lifecycle management, from logging through resolution, using modern test and project management platforms.

• Strong communication, organizational, and interpersonal skills—capable of working effectively in cross-functional Agile teams.

Preferred Qualifications

• Bachelor’s degree in Computer Science, Information Systems, or a related field.

• Experience with both manual and automated testing approaches across web and cloud-based applications.

• Exposure to multiple test environments (Dev, QA, Stage, UAT, Prod) and their configuration requirements.

• Certifications such as ISTQB, CSTE, or Agile certifications are a plus.

Why Join Us?

• Work in an established company that values innovation and growth.

• Engage with a collaborative team that is dedicated to making a meaningful impact in the energy sector.

• Gain exposure to cutting-edge projects and contribute to data-driven decision-making processes.

• Develop, implement, and maintain the company's Quality Management System (QMS) in accordance with cGMP guidelines and regulatory requirements.
• Oversee all quality control testing and batch release processes, ensuring product integrity and compliance.
• Conduct internal audits and host external regulatory inspections, ensuring readiness and compliance.
• Manage deviations, CAPAs (Corrective and Preventive Actions), and change control processes.
• Review and approve batch records, validation protocols, and other critical quality documents.
• Develop and deliver quality training programs to relevant personnel.
• Lead continuous improvement initiatives to enhance product quality and manufacturing efficiency.
• Manage and mentor the Quality Assurance team, fostering a culture of quality and compliance.
• Collaborate with R&D, manufacturing, and regulatory affairs departments to ensure quality is integrated throughout the product lifecycle.
• Monitor key quality metrics and report on the performance of the QMS to senior management.

• Develop, implement, and maintain the company's Quality Management System (QMS) in accordance with cGMP and other relevant regulations.
• Conduct internal audits and participate in external regulatory inspections (e.g., FDA, EMA).
• Review and approve batch records, validation protocols, and reports.
• Investigate deviations, out-of-specification (OOS) results, and customer complaints, implementing corrective and preventive actions (CAPA).
• Manage and maintain documentation control systems, ensuring all records are accurate, complete, and compliant.
• Perform risk assessments and implement mitigation strategies for quality-related issues.
• Oversee the qualification and validation of equipment, processes, and analytical methods.
• Train personnel on quality assurance procedures and cGMP requirements.
• Collaborate with production, R&D, and regulatory affairs departments to ensure product quality and compliance.
• Monitor and analyze quality metrics, providing regular reports to management.
• Stay updated on current regulatory guidelines and industry best practices in pharmaceutical quality assurance.
• Participate in vendor qualification and auditing programs.

• Bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific field.
• Minimum of 4 years of experience in Quality Assurance within the pharmaceutical industry.
• In-depth knowledge of cGMP, ICH guidelines, and other relevant regulatory standards.
• Experience with auditing, deviation management, CAPA, and change control processes.
• Strong analytical, problem-solving, and decision-making skills.
• Excellent written and verbal communication skills.
• Proficiency in Microsoft Office Suite and quality management software.
• Ability to work independently and as part of a team.
• Attention to detail and a strong commitment to quality.

• Develop and implement Quality Management Systems (QMS).
• Ensure compliance with cGMP, ICH, and other relevant regulations.
• Lead and manage internal and external audits.
• Oversee deviation investigations and CAPA implementation.
• Manage change control processes and document revisions.
• Review and approve batch records and quality control data.
• Conduct risk assessments and implement mitigation strategies.
• Train and mentor QA personnel.
• Collaborate with cross-functional teams to promote quality standards.

• Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related scientific field.
• Minimum of 8 years of progressive experience in pharmaceutical quality assurance.
• In-depth knowledge of cGMP regulations and quality systems.
• Experience with auditing, CAPA, change control, and validation.
• Strong leadership, communication, and interpersonal skills.
• Proven ability to interpret regulatory guidelines and implement compliance strategies.
• Experience in a hybrid work environment.
• Proficiency in quality management software.
• Detail-oriented with strong analytical and problem-solving abilities.