Quality Assurance Associate III

Pfizer • North Creek, WA

18h • Hybrid

About The Position

Every day, our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our flexible, innovative, and customer-oriented culture is rooted in science and risk-based compliance. Whether you are engaged in development, maintenance, compliance, or research analysis, your contributions have a direct impact on patient care. By being part of our team, you help uphold a quality culture that adapts and evolves to meet the needs of patients, ensuring that every product we deliver is of the highest standard. Your role is crucial in maintaining this commitment and driving forward our mission to improve patient outcomes.

Requirements

• Bachelor's degree in a scientific discipline with any years of experience, or an Associate's degree with 4 years of relevant experience, or a high school diploma (or equivalent) and 6 years of relevant experience.
• Industry experience in a cGMP/FDA regulated environment such as Manufacturing, QC or QA.
• Detail oriented team player with effective planning, organization, and execution skills.
• Excellent communication skills with internal and external personnel essential.
• Ability to work effectively at a fast pace with cross functional departments.
• Experience with quality management systems (QMS), electronic documentation management systems (eDMS) and inventory management systems (SAP).

Nice To Haves

• Experience with plant operations, pharmaceutical/biotechnology manufacturing and Quality Control analytical testing.
• Strong problem-solving skills.
• Ability to work independently and as part of a team.
• Excellent time management and multitasking abilities.
• Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance.

Responsibilities

• Perform activities within the North Creek Compliance group with a focus on Supplier Change Notifications.
• Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors.
• Contributes to the completion of specific programs and projects.
• Demonstrates good judgment in selecting methods and techniques for obtaining solutions.
• Uses ability as a Quality Professional in accordance with company policies and procedures to complete complex tasks in creative and effective ways.
• Normally receives limited instruction on day-to-day work, general instructions on new assignments.
• Independently determines and develops approach to solutions.
• Be an individual contributor with no people management responsibilities.
• Work with corporate SQM and Site functional areas to review, assess and document impact to North Creek from Supplier Change Notifications.
• Compliance with approved procedures and cGMP expectations.
• Communicate and resolve discrepancies with external and internal partners.
• Coordinate cross functional meetings to assess Supplier Change Notifications and document functional Area assessment.
• Work With external customers to obtain change notifications and required information to enable a comprehensive review.
• Act as the Responsible person for Deviations and Change Controls for associated Supplier Change Notifications.
• Work with other Compliance areas to implement corrective actions/mitigation strategies for impacted materials.
• Write and review Standard Operating Procedures as needed.
• Support other Compliance activities as needed.

Benefits

• 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution
• paid vacation, holiday and personal days
• paid caregiver/parental and medical leave
• health benefits to include medical, prescription drug, dental and vision coverage
• Relocation assistance may be available

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees