QC Associate II (Chromatography)

Genentech•Oceanside, CA

36d•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. Genentech is looking for a Quality Control Associate II in Oceanside, California. This position is primarily responsible for sample management, reagent preparation, compendial method testing, and Bulk Drug Substance testing for biopharmaceutical products. Additional responsibilities include equipment management and maintenance, and laboratory duties.

Requirements

Bachelor's Degree in Biology, Microbiology, Biochemistry, Chemistry or other relevant discipline
5-6 years of related experience
Advanced knowledge and experience with Liquid Chromatography preferred
Basic knowledge of Gas Chromatography preferred
Knowledge of Empower, GSMP, and Other Software
Excellent interpersonal, written and verbal communication skills
Must be agile and able to work independently in a fast paced environment
Proficient in time management with little to no oversight
Experience in audits and inspections with presenting topics to auditors
Computer skills - LIMS, Microsoft Office, Google Workspace
Work in office and laboratory environment
Able to stand, sit, and walk for extended periods of time
Able to lift up to 30lbs
Work with analytical instruments that may involve exposure to hazardous chemicals (corrosive, toxic, flammable, etc)
Ability to perform repetitive tasks including frequent hand and finger manipulations, grasping pushing and pulling
Available to work over-time, weekends, and holidays as needed

Responsibilities

Proficient in GMP, GLP, GDP, and Data Integrity
Prepare reagents to support routine testing
Perform routine compendial testing (pH, osmolality, color) per SOPs and GMP
Perform Bulk Drug Substance testing (HPLC, UPLC, Potency)
Perform sample management and aliquoting
Perform chemical assays according to established procedures
Perform inventory checks and stock laboratory supplies as needed
Maintain laboratory in an inspection ready state
Perform laboratory equipment maintenance
Perform calibration and standardization of equipment
Able to work independently with little supervision
Follow established safety and environmental guidelines and procedures for all work performed
Act as designee in cross-site and/or interdepartmental meeting
Facilitate team meetings as required. Attends department and corporate meetings
Attends seminars and/or classes to enhance technical or professional skills