Quality Control Associate

Roche•Oceanside, CA

2d•Onsite

About The Position

At Genentech, we are passionate about improving patients' lives and creating healthier communities for all. We foster a culture of inclusivity, integrity, and creativity while boldly pursuing answers to the world's most complex problems. We believe diversity and inclusion drives innovation and contributes to equitable healthcare access for all. At Genentech, different backgrounds and perspectives are essential. We believe every employee makes a difference. The focus of Oceanside Operations is Drug Substance bulk manufacturing. We have a passion for science, technology, innovation, professional development, and diversity and inclusion. Our vision is to have a greater overall impact and benefit to the patient. We hope you consider joining our team and being part of one of the best biotechnology facilities in the world. The Opportunity Genentech is looking for a Quality Control Associate I in Oceanside, California. This position is primarily responsible for compendial method testing, Bulk Drug Substance testing, reagent preparation, and sample management for biopharmaceutical products. Additional responsibilities include equipment management and maintenance, and laboratory duties. Analytical Techniques and Laboratory Skills: Basic understanding of Liquid/Gas Chromatography, HPLC systems, Bioassays (Potency and ELISA), aseptic techniques, and laboratory safety procedures. Experience with analytical tools like Empower and GSMP Software, as well as LIMS, Microsoft Office, and Google Workspace. Equipment Handling and Technical Expertise: Knowledge of basic equipment troubleshooting, inspections, audits, change control, and redlining SOPs. Experience in reporting and assessing unplanned events. Teamwork and Leadership: Experience working collaboratively on group projects and potentially leading them. Actively engages in team meetings, presents to peers, and shares a continuous improvement mindset for enhancing procedures or business processes. Organization and Communication: Demonstrates strong organizational, time management, and interpersonal skills, with excellent written and verbal communication. Capable of working independently in a fast-paced, dynamic environment. Knowledge of Broader Processes: Familiarity with tech transfer activities, auditing processes, and supplementary responsibilities such as attending meetings, seminars, or classes to support organizational goals. Who you are Education and Experience You possess a Bachelor’s degree in Chemistry, Biochemistry, or a related scientific discipline with 3-4 years of experience in pharmaceutical/biotech QC labs. 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)

Requirements

Bachelor’s degree in Chemistry, Biochemistry, or a related scientific discipline
3-4 years of experience in pharmaceutical/biotech QC labs
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
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).