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Job Description:

This individual will work in partnership with the Quality Control team at our client in Redmond, WA to ensure stability strategy is integrated into a program for GMP drug substances and drug products in clinical and commercial environments. This individual acts as stability support assigned program(s) and for stability quality processes and systems. The qualified person is required to have strong knowledge of stability requirements, including the studies required to support development, commercialization, and expiry strategy.

Principal Responsibilities:

• Lifecycle management of the stability program for clinical and commercial products.

• Act as the QA representative on cross-functional product teams to integrate stability activities with project milestones.

• Support the design of stability protocols to ensure that they are aligned with program strategy and regulatory requirements.

• Ensure that stability studies are executed according to protocol.

• Review, verification, disposition, and archival of stability study data for assigned programs.

• Escalate unexpected data trends, OOS events, and risks appropriately, and drive/support resolution.

• Support product stability related content in regulatory submission, including responses to questions and post-marketing.

• This position primarily interacts with analysts/associates/scientists/managers in QC and PD.

• Other QC related activities as assigned by management.

Required Qualifications:

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

• BS/BA in a relevant field

• Prior experience with stability program management or stability testing in a commercial or development environment

• Experience with stability requirements

• High competence in cGMPs and ICH requirements

• Strong scientific background and experience in the assessment of technical data and scientific information.

  We reserve the right to pay above or below the posted wage based on factors unrelated to sex, race, or any other protected classification.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. This temporary role may be eligible for the following:

• Medical, dental & vision

• 401(k)/Roth

• Insurance (Basic/Supplemental Life &

• AD&D)

• Short and long-term disability

• Health and Dependent Care Spending Accounts (HAS

• & DCFSA)

• Transportation benefits

• Employee Assistance Program

• Time off/Leave (PTO, Vacation, or Sick Leave)

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

Actalent is an equal opportunity employer.

About Actalent

Actalent connects passion with purpose. We help visionary companies advance their engineering and science initiatives through access to specialized experts that drive scale, innovation, and speed to market. With a network of almost 30,000 engineering and sciences consultants and more than 4,500 clients across the U.S., Canada, Asia, and Europe, Actalent serves many of the Fortune 500. An operating company of Allegis Group, the global leader in talent solutions, Actalent launched as a new specialized engineering and sciences services and workforce solutions brand in 2021.