Quality Control Analyst

Roche•Oceanside, CA

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. Who you are Education & Experience You possess a 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. Knowledge, Skills, and Abilities Foundational Analytical Skills: Basic knowledge in Chromatography and chemical testing assays. Includes basic equipment troubleshooting techniques and proficiency in all necessary wet chemistry methods. GMP Execution & Compliance: 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. Data & Systems Proficiency: Proficiency with laboratory electronic systems, including LIMS and Microsoft Office. Working knowledge of Empower or GSMP software is preferred. Agile Teamwork & Organization: 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. Quality Mindset & Communication: Excellent interpersonal, written, and verbal communication skills. Possesses a continuous improvement mindset and basic experience supporting audit or inspection activities. Work in office and laboratory environments. Physical & Work Environment Requirements 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. Relocation benefits are available for this posting The expected salary range for this position based on the primary location of California is $45,200 - $75,800 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 also qualifies for the benefits detailed at the link provided below. Benefits 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. Who We Are Genentech, a member of the Roche group and founder of the biotechnology industry, is dedicated to pursuing groundbreaking science to discover and develop medicines for people with serious and life-threatening diseases. To solve the world's most complex health challenges, we ask bigger questions that challenge our industry and the boundaries of science to transform society. Our transformational discoveries include the first targeted antibody for cancer and the first medicine for primary progressive multiple sclerosis. The next step is yours. To apply today, click on the "Apply for this job" button. 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.

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