Quality Control Associate I

GenentechOceanside, CA
Hybrid

About The Position

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 (raw material), reagent preparation, and sample management for biopharmaceutical products. Additional responsibilities include equipment management and maintenance, and laboratory duties.

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.
  • Basic equipment troubleshooting techniques and proficiency in all necessary wet chemistry methods.
  • Experience working in a GMP environment with the ability to read and follow Standard Operating Procedures precisely.
  • Knowledge of laboratory safety procedures and basic experience supporting quality events.
  • Proficiency with laboratory electronic systems, including LIMS and Microsoft Office.
  • Excellent organizational skills and the ability to be agile and work independently in a fast-paced environment.
  • Experience working on group projects and proficient in time management with oversight.
  • Excellent interpersonal, written, and verbal communication skills.
  • Possesses a continuous improvement mindset and basic experience supporting audit or inspection activities.

Nice To Haves

  • Working knowledge of Empower or GSMP software is preferred.

Responsibilities

  • Execute and document routine and non-routine compendial testing, including pH, osmolality, Karl Fischer, basic wet chemistry, and other general techniques according to established procedures.
  • Perform specialized chemical assays and analysis, collect and process data, and ensure results are reported accurately and on time.
  • Perform daily and periodic laboratory equipment maintenance, including calibration and standardization of equipment, to ensure continuous readiness and compliance.
  • Perform basic troubleshooting of chemical assays and provide initial support for instrument issues to minimize downtime.
  • Manage laboratory supplies by performing inventory checks and stocking supplies as needed (e.g., preparing reagents).
  • Assist in data trending and data review for conformance to specifications.
  • Assist with or lead laboratory investigations OOS/OOT with appropriate oversight.
  • Train others in basic to complex laboratory and troubleshooting techniques.
  • Serve as a liaison for daily activities and special projects within QC or cross-functionally.
  • Demonstrate the ability to work independently with little supervision and provide support for the execution of studies and protocols as needed.

Benefits

  • A discretionary annual bonus may be available based on individual and Company performance.
  • The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.
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