Quality Control Associate II

Job Summary

We are seeking an experienced QC Associate II to support direct material (raw material) testing. This role requires technical proficiency in chemical assays and compendial testing, balancing hands‑on routine and non‑routine analysis with significant responsibility in technical expertise, troubleshooting, and training. The successful candidate will maintain the lab in an audit‑ready and compliant manner, apply strong analytical and interpretive skills to investigate anomalous data OOS/OOT, drive process improvements, and contribute to regulatory documentation and Technical Transfer activities to ensure the long‑term technical competence and efficiency of the laboratory.

• Serve as the site SME for complex technical troubleshooting of established methods and instrumentation.
• Initiate and drive OOS/OOT laboratory investigations.
• Act as a technical liaison for method performance issues and continuous improvement projects.
• Collaborate with external sites and Validation teams on Analytical Method Transfer Protocols.
• Technical testing of compendial and non‑compendial methods including FTIR, NIR, HPLC, UV/Vis, GC, wet chemistry, MS, Karl Fischer, and titration.
• Collect, process, and report data for direct material and in‑process testing from clinical and commercial manufacturing facilities.
• Translate knowledge transfer into SOPs and serve as the primary instructor for junior analysts, managing proficiency testing and overseeing on‑the‑job training.
• Initiate, compile, and perform lab investigations that include reviewing documents, conducting internal and external interviews, and tracking information.
• Responsible for collecting, entering data, and generating reports from electronic systems.
• Ensure integration of environmental health, safety, and security into business processes, reporting safety and environmental incidents, and fostering a positive safety culture.
• All employees with jobs that require access to the Warehouse must be able to pass the Transportation Security Administration (TSA) Security Threat Assessment (STA).

• Bachelor’s degree in Chemistry, Biochemistry, or a related scientific discipline.
• 5‑6 years of experience in pharmaceutical/biotech QC labs, including hands‑on raw material testing under cGMP.
• Proven experience with analytical instrumentation and techniques, including method development, validation, and troubleshooting.
• Advanced Analytical Proficiency:
  Expertise in Liquid HPLC and/or Gas Chromatography, system configuration, operation, and basic equipment troubleshooting.
• Experience with general chemical testing assays.
• Extensive experience working in a GMP environment with a strong understanding of laboratory safety procedures.
• Demonstrated experience in audits and inspections, and ability to interact with auditors.
• Continuous improvement mindset with a proven track record of improving procedures or assays.
• Experience working effectively on group projects and engaging in team meetings.
• Excellent interpersonal, written, and verbal communication skills, and demonstrated leadership ability in a group setting.
• Proficiency in laboratory electronic systems, including LIMS and Microsoft Office Suite/Google Workspace; knowledge of Empower and/or GSMP software.
• Ability to work independently in a fast‑paced environment with high volume testing schedules and excellent organizational skills.

• Must be able to stand, walk, and use laboratory equipment for extended periods.
• Ability to lift up to 35 lbs and wear necessary personal protective equipment (PPE).
• Work performed in a cGMP‑regulated manufacturing facility.
• Travel may be up to 25% during start‑up laboratory activities; no more than 10% routine travel.
• Relocation benefits are not available for this posting.

Expected salary range based on the primary location of California is $66,200 – $110,000 annual. Actual pay will be determined based on experience, qualifications, geographic location, and other job‑related factors permitted by law. A discretionary annual bonus may be available based on individual and company performance. This position qualifies for the company benefits described at the provided link.

Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. 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.

If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.