Easter Seals Jobs

Job Title: Quality Assurance Associate

Job Description

As a Quality Assurance Associate, you will manage the stability program for clinical and commercial products. Your responsibilities will include acting as the QA representative on cross-functional product teams to integrate stability activities with project milestones. You will support the design of stability protocols to ensure alignment with program strategy and regulatory requirements, ensure stability studies are executed according to protocol, and handle review, verification, disposition, and archival of stability study data for assigned programs. Additionally, you will escalate unexpected data trends, Out of Specification (OOS) events, and risks appropriately while driving or supporting resolution. You will also interpret stability results to support expiry, trending, and conditions of products, and support product stability related content in regulatory submissions, including responses to questions and post-marketing.

Hard Skills

• 3+ years of relevant experience in the biotech or pharmaceutical industry

• BS/BA in a relevant field

• Experience with stability program management or stability testing

• Knowledge of stability requirements

• Competence in cGMPs and ICH requirements

Soft Skills

• Strong scientific experience

• Experience in the assessment of technical data and scientific information

Job Type

This is a Contract-to-Hire position with a duration of 6 Month(s).

Work Site

This is a fully on-site position

Work Environment

Onsite at facility in Redmond

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 actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.