Genentech · 18 hours ago
QC Associate II, Direct Material (Raw Material)
Oceanside, CA
Full-time
Onsite
Mid, Senior Level
$66K/yr - $123K/yr
5+ years expGenentech is a leading biotechnology company, and they are seeking an experienced QC Associate to support direct material testing. The role involves technical proficiency in chemical assays and compendial testing, maintaining lab compliance, and driving process improvements while overseeing training and documentation for junior analysts.
BiotechnologyLife ScienceManufacturing
Responsibilities
Serves as the site SME for complex technical troubleshooting of established methods and instrumentation
Initiates and drives OOS/OOT laboratory investigations
Acts as a technical liaison for method performance issues and continuous improvement projects
Works in close collaboration with the external sites and Validation teams to execute and verify Analytical Method Transfer Protocols
Technically capable for testing of compendial and non-compendial methods such as but not limited to: FTIR, NIR, HPLC, UV/Vis, GC, wet chemistry, MS, Karl Fischer, and titration
Collect, process and report on data for samples associated with direct material (raw material) and in-process testing from the clinical and/or commercial manufacturing facilities
Translates knowledge transfer into SOPs
Serves 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
Ensures the integration of environmental health, safety, and security into the business processes, systems, and programs while reporting safety and environmental incidents including injuries, illnesses, and safety suggestions within one’s functional area
Qualification
Required
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: Proven expertise in Liquid HPLC and/or Gas Chromatography, including system configuration, operation, and basic equipment troubleshooting techniques
Must have experience in general chemical testing assays
GMP Compliance & Quality Systems: Extensive experience working in a GMP environment with a strong understanding of laboratory safety procedures
Audit & Regulatory Interaction: Demonstrated experience in audits and inspections, including the ability to interact with and speak to auditors
Process Improvement & Teamwork: Possesses a continuous improvement mindset and actively seeks ways to improve procedures or assays
Experience working effectively on group projects and actively engaging in team meetings
Communication & Leadership: Excellent interpersonal, written, and verbal communication skills
Includes the ability to read and interpret technical data and demonstrated leadership ability in a group setting
Data & Computer Systems Proficiency: Proficiency in laboratory electronic systems, including LIMS and Microsoft Office Suite and/or Google Workspace
Must have working knowledge of Empower and/or GSMP software
Execution, Agility, & Organization: Must be agile and able to work independently in a fast-paced environment with high volume testing schedules
Demonstrates excellent organizational skills and proficiency in time management
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 is performed in a cGMP-regulated manufacturing facility
All employees with jobs that require access to the Warehouse must be able to pass the Transportation Security Administration (TSA) Security Threat Assessment (STA)
Ensures the integration of environmental health, safety, and security into the business processes, systems, and programs while reporting safety and environmental incidents including injuries, illnesses, and safety suggestions within one's functional area
Benefits
Relocation benefits are available for this posting
A discretionary annual bonus may be available based on individual and Company performance.
Company
Genentech
Genentech is a biotechnology research company that specializes in genetic testing and personalized medicines.
10001+ employees
H1B Sponsorship
Genentech has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (167)
2024 (148)
2023 (150)
2022 (178)
2021 (121)
2020 (158)
Funding
Current Stage
Public CompanyTotal Funding
unknown2009-03-26Acquired
1999-07-20IPO
1976-01-01Series Unknown
Leadership Team
Ashley Magargee
Chief Executive Officer
Michael Laird
Vice President, Global MSAT Drug Substance Biologics Technology and Commercial Products Support
Recent News
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2026-02-05
Bizjournals.com Feed (2025-11-12 15:43:17)
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2026-02-04
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