QC Sr. Associate ; QC Lab LIMS Specialist

In the QC Sr. Associate I (QC Lab Support LIMS Specialist) role, you will act as Oceanside QC’s subject‑matter expert for computer systems such as Next Lab, LIMS, SAP, Empower, Tableau and more. You will perform technical and compliance laboratory activities that support QC operations.

• Perform data review, investigate discrepancies and out‑of‑specification events.
• Lead troubleshooting of assay failures and equipment issues.
• Support areas such as Microbiology, Bioassays, Adventitious Agents, Product Testing, Stability, Analytical Science & Technology, Validation, and Lab Support.
• Exercise judgment in selecting methods, techniques and evaluation criteria to obtain results.
• Interact with senior internal and external personnel and represent the organization as a primary contact on initiatives and projects.
• Ensure adherence to company quality policies, SOPs and federal regulations.
• Ensure product(s) consistently meet customer and regulatory requirements by developing, improving or implementing processes, concepts and strategies.
• Provide direction to employees to schedule, manage and oversee routine activities and initiatives of moderate complexity.
• GMP compliance & system management: ensure computer systems are compliant and fit for use; approve major upgrades, replacements and retirements through change‑management processes.
• Access control & data integrity: oversee system access procedures, review user lists, determine verification methods and propose strategies to improve data accuracy.
• Issue management & communication: manage escalation of issues to Business or IT, communicate and document status and ensure timely quality decisions.
• Validation strategy & testing support: provide input into validation test strategy and offer technical support for analytical, microbiological and cell‑based test methods, control systems and equipment.
• Scientific problem‑solving & analysis: apply advanced theory, technical principles and expert judgment to solve difficult problems; present scientific data at meetings.
• Scientific documentation: author, review and approve QC scientific documents including validation plans, protocols, reports, and annual process monitoring documentation.
• Experimental design & implementation: design and execute experiments to support QC improvement initiatives from proof‑of‑concept to final report.
• Equipment & system maintenance: manage maintenance of QC equipment including calibration, qualification and system suitability testing for cGMP activities.
• Quality reporting & initiatives: support QC with quality reports such as Methods Monitoring and Annual Products Review; lead or participate in design and implementation of department and cross‑functional initiatives.
• Investigation & regulatory oversight: define and direct investigation efforts, oversee assembly, review, approval of scientific and technical reports, and present documentation to regulatory agencies.
• Quality issue resolution & stakeholder management: facilitate resolution of quality issues affecting product and supply by partnering with key stakeholders and performing high‑level interactions across departments.
• Leadership & development: coach and mentor staff, oversee junior-level activities as assigned, and align projects with strategy and business objectives.

• Bachelor’s degree in Life Science (Biology or Biochemistry) or equivalent, plus a minimum of 5 years of related/relevant experience, or an advanced degree with 3 years of equivalent experience.
• Minimum 5 years experience in pharmaceutical quality control.

• Competitive salary range $90,100–$167,300 (annual).
• Discretionary annual bonus (may be available).
• Access to Genentech benefits as detailed in the provided link.
• Relocation benefits are not available for this posting.

Genentech is an equal‑opportunity employer. We employ, promote and otherwise treat all employees and applicants on the basis of merit, qualifications and competence. The company’s policy prohibits unlawful discrimination under applicable federal, state and local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing the Accommodations for Applicants form.