Job Title: Quality Assurance Associate

Job Description

We are seeking a dedicated Quality Assurance Associate to manage the stability program for clinical and commercial products. The ideal candidate will act as the QA representative on cross-functional product teams, ensuring that stability activities are integrated with project milestones and aligned with program strategy and regulatory requirements.

ResponsibilitiesAct 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, verify, dispose, and archive stability study data for assigned programs.Escalate unexpected data trends, out-of-specification (OOS) events, and risks appropriately, and drive/support resolution.Interpret stability results to support expiry, trending, and conditions of products.Support product stability-related content in regulatory submissions, including responses to questions and post-marketing activities.Interact primarily with analysts, associates, scientists, and managers in Quality Control (QC) and other related activities as assigned by management.Essential SkillsQuality assuranceBatch record reviewQuality controlAuditCorrective and Preventive Actions (CAPA)InspectionStandard Operating Procedures (SOP)Document controlAdditional Skills & Qualifications3+ years of relevant experience in the biotech or pharmaceutical industryBS/BA in a relevant fieldPrior experience with stability program management or stability testing in a commercial or development environmentExperience with stability requirementsHigh competence in current Good Manufacturing Practices (cGMPs) and International Council for Harmonisation (ICH) requirementsStrong scientific experience in the assessment of technical data and scientific informationWork Environment

This position is onsite at the JPOD Facility in Redmond. The work environment includes interaction with various teams and handling of technical data and scientific information. The facility adheres to cGMPs and ICH requirements.

Pay and Benefits

The pay range for this position is $40.00 - $50.00

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Seattle,WA.

Application Deadline

This position will be accepting applications until Dec 27, 2024.

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 for other accommodation options.