Quality Control Analyst

Genentech

1d • Onsite

About The Position

A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That’s what makes us Roche.

The Opportunity
We are seeking Quality Control Analyst II to support direct material (raw material) testing, in- process, and drug substance testing. As a Quality Control Analyst II, 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.
Technical Expertise and Routine Activities: Knowledgeable in GMP, GLP, GDP, and Data Integrity; prepare reagents, perform routine testing (e.g., pH, osmolality, color), chemical assays, sample management, and aliquoting while adhering to SOPs and GMP.
Troubleshooting, Maintenance, and Calibration: Perform basic troubleshooting of chemical assays, laboratory equipment maintenance, calibration, and standardization of equipment, and stock laboratory supplies as needed.
Laboratory and Compliance Responsibilities: Maintain the laboratory in an inspection-ready state, ensure safety and environmental compliance, and follow established guidelines and procedures for all work performed.
Collaborative and Independent Work: Participate in projects, studies, and protocols as required; attend team, department, and corporate meetings, while being able to work independently with little supervision.
Training and Development: Attend seminars and/or classes as necessary to support business needs and professional growth.

Requirements

• Bachelor’s degree in Chemistry, Biochemistry, or a related scientific discipline with 0-2 years 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
• 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

• support direct material (raw material) testing, in- process, and drug substance testing
• responsible for compendial method testing, direct material (raw material), reagent preparation, and sample management for biopharmaceutical products
• equipment management and maintenance, and laboratory duties
• prepare reagents, perform routine testing (e.g., pH, osmolality, color), chemical assays, sample management, and aliquoting while adhering to SOPs and GMP
• Perform basic troubleshooting of chemical assays, laboratory equipment maintenance, calibration, and standardization of equipment, and stock laboratory supplies as needed
• Maintain the laboratory in an inspection-ready state, ensure safety and environmental compliance, and follow established guidelines and procedures for all work performed
• Participate in projects, studies, and protocols as required
• attend team, department, and corporate meetings, while being able to work independently with little supervision
• Attend seminars and/or classes as necessary to support business needs and professional growth.

What This Job Offers

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