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Quality Engineer

2 months ago

Irvine, United States Actalent Full time

Job Title: Quality EngineerJob Description

Manage the process for generation of Annual Product Review (APR) for drug products as per the APR procedural guidelines and requirements. Collaborate closely with stakeholders and subject matter experts during the APR generation process to ensure that deliverables are met in a timely manner while upholding quality standards. Lead and participate on Site Data Integrity projects to ensure that deliverables for the Site Data Integrity Program are being met consistently, including performing Periodic Reviews of Electronic Data (computerized systems) as per site procedures. Lead and manage quality systems projects to promote process improvements and address quality risks and issues. Facilitate and lead cross-functional project meetings with stakeholders, create project schedules, and ensure adherence to agreed-upon timelines. Work closely with cross-functional teams, including product design, project management, and production to identify and mitigate quality risks.

Hard Skills

  • Generation of Annual Product Review (APR)

  • Periodic Reviews of Electronic Data

  • Quality systems project management

  • Process improvement

  • Quality risk management

Soft Skills

  • Collaboration

  • Stakeholder management

  • Leadership

  • Cross-functional team coordination

  • Timely delivery

Job Type

This is a contract position with a duration of 6 Month(s).

Work Site

This is a fully on-site position in Irvine, California.

Work Environment

Medical device manufacturing/pharmaceutical company with over 2000 employees in Irvine.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are Embedded into our culture through:

  • Hiring diverse talent

  • Maintaining an inclusive environment through persistent self-reflection

  • Building a culture of care, engagement, and recognition with clear outcomes

  • Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email (see below) (% (see below) ) for other accommodation options.