Quality Control Analyst at Roche in Oceanside

Summary: Roche is a company dedicated to innovating healthcare solutions. They are seeking a Quality Control Analyst II to support testing for biopharmaceutical products, including direct material testing and laboratory maintenance responsibilities. 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 - 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 Required Qualifications: - Bachelor's degree in Chemistry, Biochemistry, or a related scientific discipline - 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 - 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 - 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) - Travel may be up to 25% during start-up laboratory activities. No more than 10% travel expected during routine operations Preferred Qualifications: - Working knowledge of Empower or GSMP software Required Skills: GMP, Chromatography, Laboratory electronic systems Important Skills: Chemical testing assays, Data Integrity Benefits: Relocation benefits are available for this posting, A discretionary annual bonus may be available based on individual and Company performance.