Quality Control Associate

Genentech • Hillsboro, OR

2d • Onsite

About The Position

This position is part of a consolidated Analytical Development and Quality Control (ADQC) team within Genentech’s cutting edge Pharma Technical Cell and Gene Therapy (PTC) organization. PTC is dedicated to advancing cell and gene therapies aimed at treating or curing various diseases. In this position, you'll support development and conduct quality control (QC) activities to support the clinical progress of cell and gene therapies.
As a member of Genentech’s Hillsboro Innovative Therapies (HIT) QC team, you will perform analyses of cellular attributes and secreted molecules from experimental samples, in-process samples, and finished products, including cell-based functional, biochemical and chemical tests. You will gather data for test procedure documentation, calibrate and maintain laboratory equipment, and contribute to drafting procedures, summaries, reports and investigations. Additionally, you will support activities for method improvements and method lifecycle.
The Opportunity:
As a QC Associate, you will support the clinical development and manufacturing of cell therapies by performing analytical development and quality control activities to ensure product quality, compliance, and timely delivery. You will contribute to analytical method validation, transfer, troubleshooting, and operational excellence in collaboration with global, cross-functional teams. Additionally, you will:

Requirements

• You possess a Bachelor’s degree and at least 3 years of relevant experience, or a Master’s degree with one year of experience, or an equivalent combination of education and experience in Chemistry, Biochemistry, Molecular Biology, or a related scientific discipline within the pharmaceutical or biopharmaceutical industry.
• You have sound knowledge of cGMPs or equivalent regulations and the ability to interpret and apply Quality standards for implementation and review.
• You demonstrate the ability to work independently to accomplish tasks and apply scientific theories, principles, and techniques used in analytical or biological test procedures.
• You have strong verbal and written communication skills, with the ability to organize and present information clearly both formally and informally.
• You show flexibility in problem-solving, adapting to work hours, and meeting business objectives while maintaining a high standard of work.
• You can work in an office and laboratory environment, with prolonged periods of standing/sitting at lab bench tops, frequent lifting (up to 25 lbs), bending, reaching, twisting, and use of stepladders and pushcarts.
• You meet physical requirements such as passing visual screening and may travel to other sites as required.

Responsibilities

• Validate, qualify, and troubleshoot analytical methodologies to support clinical production and GMP operations.
• Execute and oversee analytical testing activities related to process development, IPC, and product release.
• Collaborate with technical development teams, PTC functions, and global stakeholders to align on project timelines, quality criteria, and regulatory compliance.
• Develop and implement SOPs, specifications, and testing methods, ensuring compliance with cGMP regulations and continuous improvement principles.
• Conduct technical review of data and identify gaps, deviations, or discrepancies, escalating issues as needed.
• Perform equipment qualification, maintenance, and validation of laboratory instruments and computer systems.
• Support internal and external audits and regulatory inspections while contributing to the evolution of business processes and operational excellence initiatives.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level