Quality Control Associate I

4h4 hours ago

Genentech

Oceanside, US · Full-time · $52,600 – $84,000

About this role

We are seeking a QC Associate to support direct material (raw material) testing. As a Quality Control Associate I, you will be responsible for compendial method testing, direct material testing, reagent preparation, and sample management for biopharmaceutical products. This role also involves equipment management and maintenance, as well as general laboratory duties.

You will execute and document routine and non-routine compendial testing including pH, osmolality, Karl Fischer, and basic wet chemistry. Perform specialized chemical assays, collect and process data, and ensure accurate and timely reporting. Daily equipment maintenance and calibration are also key responsibilities.

The laboratory operates under strict GMP, GDP, and Data Integrity ALCOA principles. You will maintain an inspection-ready state through 5S implementation and assist with investigations and data review. Collaboration with cross-functional teams and training others in laboratory techniques is expected.

This role offers the chance to develop expertise in raw material testing and compendial methods within a leading biopharmaceutical company. You will work independently with little supervision and support studies and protocols, building a strong foundation for career advancement in quality control.

Requirements

Bachelor’s degree in Chemistry, Biochemistry, or a related scientific discipline.
3-4 years of experience in pharmaceutical/biotech QC labs, including hands-on raw material testing under cGMP.
Basic knowledge in chromatography and chemical testing assays, including equipment troubleshooting and wet chemistry methods.
Experience working in a GMP environment with ability to read and follow SOPs precisely.
Proficiency with laboratory electronic systems including LIMS and Microsoft Office; working knowledge of Empower or GSMP software preferred.
Excellent organizational skills and ability to work independently in a fast-paced environment.
Excellent interpersonal, written, and verbal communication skills with a continuous improvement mindset.
Must be able to stand, walk, and use laboratory equipment (physical requirements).

Responsibilities

Apply advanced knowledge of GMP, GDP, and Data Integrity ALCOA principles daily to ensure compliance and quality system adherence.
Execute and document routine and non-routine compendial testing including pH, osmolality, Karl Fischer, and basic wet chemistry.
Perform specialized chemical assays and analysis, collect and process data, and ensure accurate and timely reporting.
Perform daily and periodic laboratory equipment maintenance, including calibration and standardization.
Perform sample management and aliquoting, and manage laboratory supplies through inventory checks and stocking.
Assist in data trending and data review for conformance to specifications, and assist with or lead laboratory investigations (OOS/OOT).
Train others in basic to complex laboratory and troubleshooting techniques and serve as a liaison for daily activities and special projects.
Demonstrate ability to work independently with little supervision and provide support for execution of studies and protocols.