Quality Assurance Scientist I

Job Summary

We are seeking a Quality Assurance Scientist to provide daytoday QA support review and approval of GMP documentation and activities. This role supports SOPs master batch records and methods and participates in troubleshooting quality issues across Manufacturing QC Engineering (EOS) and Warehousing.

The QA team plays a handson role in ensuring compliance supporting investigations and CAPAs and partnering crossfunctionally to maintain GMP standards across site operations.

About the Quality Assurance Team

You will join a Quality Assurance team responsible for providing realtime quality support and oversight across manufacturing and support functions. The team partners closely with Manufacturing QC Engineering and Warehouse teams to ensure compliance issue resolution and continuous improvement in a regulated GMP environment.

Key Responsibilities

• Provide daily quality support and oversight for designated functional areas including Manufacturing Engineering (EOS) QC and Warehouse operations.

• Review and approve GMP documentation such as SOPs master batch records and methods for accuracy and compliance.

• Review executed batch records for completeness accuracy and GMP compliance; partner with stakeholders to resolve documentation issues.

• Facilitate deviation investigations CAPAs and change records for simple to moderate issues.

• Identify and escalate potential compliance risks and quality concerns.

• Participate in troubleshooting activities related to QC Manufacturing and preventive maintenance.

• Provide technical guidance and quality leadership within assigned work areas.

• Coordinate with crossfunctional teams to meet business needs and output requirements.

• Support prioritization and execution of project goals within the work area.

• Coach team members on task execution and skill proficiency with manager guidance.

Skills & Competencies

• Demonstrated technical proficiency in quality systems and GMP operations.

• Ability to communicate clearly within the team and increasingly across functional groups.

• Works closely with management and applies guidance to deliver effective results.

• Proactively identifies needs and potential issues based on prior experience.

• Begins to support the development and guidance of junior team members.

Qualifications & Experience

Required:

• Bachelors degree with 5 years of relevant experience or

• Masters degree with 2 years of relevant experience or

• PhD (or equivalent) with 02 years of experience including postdoctoral experience where applicable.

• Equivalent education and experience may be considered.

Formalities

• Location: Bothell WA

• Schedule: Fulltime Monday through Friday

• Compensation: $83920 - $115390