Quality Control Associate

Genentech

2d • $51,000 - $94,600 • Onsite

About The Position

We are seeking 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. The Opportunity Compliance and Quality System Adherence: Apply advanced knowledge of GMP, GDP, and Data Integrity ALCOA principles daily. Follow established safety and environmental guidelines and maintain the laboratory in an inspection-ready state (e.g.,5S implementation). Core Compendial Testing: 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. Chemical Assay Execution: Perform specialized chemical assays and analysis, collect and process data, and ensure results are reported accurately and on time. Equipment Maintenance and Readiness: Perform daily and periodic laboratory equipment maintenance, including calibration and standardization of equipment, to ensure continuous readiness and compliance. Technical Support and Troubleshooting: Perform basic troubleshooting of chemical assays and provide initial support for instrument issues to minimize downtime. Materials and Inventory Management: Perform sample management and aliquoting. Manage laboratory supplies by performing inventory checks and stocking supplies as needed (e.g., preparing reagents). Investigation and Data Review: Assist in data trending and data review for conformance to specifications. Assist with or lead laboratory investigations OOS/OOT with appropriate oversight. Training and Cross-Functional Liaison: 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. Independent Execution: Demonstrate the ability to work independently with little supervision and provide support for the execution of studies and protocols as needed

Requirements

• Bachelor’s degree in Chemistry, Biochemistry, or a related scientific discipline.
• 3-4years of experience in pharmaceutical/biotech QC labs, including hands-on raw material testing under cGMP.
• Basic knowledge in Chromatography and chemical testing assays. Includes 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. Possesses knowledge of laboratory safety procedures and basic experience supporting quality events.
• Proficiency with laboratory electronic systems, including LIMS and Microsoft Office. Working knowledge of Empower or GSMP software is preferred.
• Demonstrates 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.
• 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.
• Work with analytical instruments that may involve exposure to hazardous chemicals (corrosive, toxic, flammable, etc)

Nice To Haves

• Working knowledge of Empower or GSMP software is preferred.

Responsibilities

• compendial method testing
• direct material (raw material) testing
• reagent preparation
• sample management for biopharmaceutical products
• equipment management and maintenance
• laboratory duties
• Apply advanced knowledge of GMP, GDP, and Data Integrity ALCOA principles daily
• Follow established safety and environmental guidelines and maintain the laboratory in an inspection-ready state (e.g.,5S implementation)
• 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
• Perform sample management and aliquoting
• 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

• Relocation benefits are available for this posting
• A discretionary annual bonus may be available based on individual and Company performance.
• This position also qualifies for the benefits detailed at the link provided below.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees