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Quality Assurance Engineer Ii

Company

Polaris Pharmaceuticals Inc.

Address Vacaville, CA, United States
Employment type FULL_TIME
Salary
Category Biotechnology Research,Pharmaceutical Manufacturing
Expires 2023-08-16
Posted at 9 months ago
Job Description

Role Title Quality Assurance Engineer II

Department Quality

Supervisor Senior Manager Quality Engineer

FLSA Exempt

CORE VALUES

Respect ● Passion ● Teamwork ● Integrity ● Honesty ● Commitment ● Collaboration

FUNCTION SUMMARY Quality Assurance Engineer II

The Quality Assurance (QA) Engineer II provides strategic direction for new product development and design change teams in terms of quality functions including design quality, manufacturing quality, process validation, supplier quality and risk management. This person will develop and execute exploratory and automated tests to ensure product quality. The QA Engineer II’s responsibilities include designing and implementing tests, in addition to debugging and defining corrective actions. This person will also review system requirements and track quality assurance metrics. This role plays an important part in our Company’s product development process. Our ideal candidate will be responsible for conducting tests before product launches to ensure software runs smoothly and meets client’s needs, while being cost-effective. Ultimately this person should monitor all stages of software development to identify and resolve system malfunctions to meet quality standards.

Duties & Responsibilities:

  • Assist with management and development of assigned Quality Engineers.
  • Review and approve process validation test plans, protocols and reports.
  • Act as Project Quality Manager and implement the Requirements of the Quality Management System on assigned projects.
  • CAPA root cause investigation execution, implementation of corrective and preventative actions to improve quality processes.
  • Provide advice and guidance on the application of the Quality Management System on projects to both assigned Quality Engineers and Project Management.
  • And analyze test results to report defects and issues found during test runs.
  • Or modify and execute tests based on manual test cases, functional requirements or existing functionality of the system for product/project releases.
  • Assist with the roll out and implementation of Continual Improvement initiatives.
  • A leader of and enforce Agile principles within the product development team.
  • Resolution of issues by following through to the end of the testing process.
  • Guide Quality Incident (non-conformance) and CAPA investigational activities ensuring thorough root cause analysis and appropriate corrective actions,
  • Relationships with peers and other teams to achieve objectives, maintain objectivity, and give and welcome feedback on design/implementation decisions.
  • Responsible for supporting improvement of supplier quality management of multiple manufacturing sites.
  • Develop and build/maintain both manual and automated tests.
  • Directly with cross-functional teams and be responsible for ensuring the team is producing high quality software.
  • Review project specific procedures and documents to verify that they comply with the contractual requirements.

Skills & Competencies

  • Extensive data feed testing understands data mapping, ETL, and understanding complex data transformations.
  • Automation experience testing data feeds MQ, FTP, with FIX, XML data formats.
  • Ability to rapidly learn new technologies based on business needs.
  • Sound analytic skills to deal with requirements and/or issues that may be loosely defined and the ability to further manipulate and expand on them.
  • Must be agile and proactive to aggressively learn and work in a competitive time sensitive environment.
  • Requires a polished individual with strong leadership skills and extraordinary people management skills, who has a solid understanding of the quality process and manufacturing operations to keep the Company a step ahead of their competitors.

Education & Experience

  • Master's degree in Computer Science, Computer Engineering, or a related field is preferred.
  • Scripting/Programming experience (Javascript, Ruby/C#/Java, VB).
  • 5-7+ years of relevant work experience.
  • Bachelor’s degree in Computer Science and Engineering, quality technology or equivalent.
  • Knowledge and deep understanding of Waterfall/Agile SDLC methodologies
  • Knowledge of and experience with bug tracking systems.
  • Networking and network testing tools (Wireshark, Charles, Fiddler, Firebug).
  • Knowledge of SaaS, web services, and service-oriented architectures.
  • Continuous Integration tools (Travis, Bamboo, Jenkins/Hudson, CruiseControl).
  • Experience collaborating with programmers and business experts to capture critical workflows for test purposes.
  • CGMP manufacturing experience is desired.
  • Load & Performance Testing tools (JMeter, LoadRunner, IBM Performance Tester).
  • Basic understanding of statistics and statistical process control preferred.
  • Experience with NoSQL databases (MongoDB, Solr).