In the QC Sr. Associate I (QC Lab Support LIMS Specialist) role, your primary responsibility is to act as Oceanside QC’s subject matter expert for computer systems such as NextLab, LIMS, SAP, Empower, Tableau etc. In addition, you will perform technical and compliance laboratory related activities that support QC operations. Performs data review; discrepancy and out-of-specification investigation. Leads troubleshooting of assay failures and equipment issues.
Supports one or more of the following areas: Microbiology, Bioassays, Adventitious Agents, Product Testing, Stability, Analytical Science and Technology, Validation and Lab Support by applying extensive theoretical and cross-functional expertise in the context of company objectives to independently address complex problems.
Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results. Interacts with senior internal and external personnel on significant matters. Represents organization as a prime contact on initiatives and projects. Ensures adherence to and compliance with established company quality policies, practices, SOPs federal regulations. Ensures that Oceanside product(s) consistently meets customer and regulatory requirements by developing, improving, and/or implementing processes, concepts and strategies.
May provide direction to employees to schedule, manage and oversee routine activities and initiatives of moderate complexity.
The Opportunity
Subject Matter expertise for Computer Systems (e.g., LIMS, SAP, Empower, Tableau Software)
GMP Compliance & System Management: Ensure GMP computer systems are compliant and fit for intended use; approve major upgrades, replacements, and retirements through change management processes
Access Control & Data Integrity: Oversee system access procedures including periodic review of user access lists; determine verification methods and propose strategies to achieve better data accuracy
Issue Management & Communication: Manage escalation of issues to Business or IT; communicate and document status of issues where appropriate; ensure timely quality decisions to meet requirements and timelines
Validation Strategy & Testing Support: Give input into and help define validation test strategy; provide technical support for analytical, microbiological, and cell-based test methods, control systems, and equipment as needed
Scientific Problem-Solving & Analysis: Apply advanced theory, technical principles, and expert judgment to address difficult problems; present scientific data and concepts at department, project team, and staff meetings
Scientific Documentation: Author, review, and approve QC scientific documents including validation project plans, protocols, reports, and annual process monitoring documentation as applicable
Experimental Design & Implementation: Design and execute experiments to support QC improvement initiatives from proof-of-concept to robust test product and final report
Equipment & System Maintenance: Manage maintenance of QC equipment including calibration, qualification, and system suitability testing for cGMP activities as applicable
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 to maximize efficiency and timely resolution; oversee assembly, review, and approval of scientific and technical reports; interact with 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; perform high-level interactions across Genentech departments to resolve GMP issues; notify management of potential quality or regulatory issues
Leadership & Development: Actively coach and mentor staff on a regular basis to ensure high level of technical acumen in QC; may oversee activities of junior-level team members as assigned; work with management to align projects to strategy and business objectives
Who you are
Bachelor’s degree in Life Science (Biology or Biochemistry) or equivalent and a minimum of 5 years of related/relevant experience; or an advanced degree with 3 years of equivalent work experience.
Minimum 5 years pharmaceutical experience
Minimum 5 years experience in Quality Control
Relocation benefits are not available for this posting
The expected salary range for this position based on the primary location of California is $90,100 - $167,300 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.
Skills Required
- Bachelor's degree in Life Science or equivalent
- 5 years of pharmaceutical experience
- 5 years of Quality Control experience
Genentech Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Genentech and has not been reviewed or approved by Genentech.
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Healthcare Strength — Health coverage is described as comprehensive across medical, dental, vision, mental health, and prescriptions, supported by HSAs/FSAs and broad wellness resources. On‑site fitness and health centers, mental‑health clinicians, and specialized programs like fully covered preventive cancer screenings and menopause support deepen the offering.
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Retirement Support — Retirement benefits feature a 401(k) with up to a 4% company match plus an additional annual 6% company contribution to eligible pay. Additional financial protections such as life and accident insurance complement salary, bonuses, and stock options.
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Leave & Time Off Breadth — Time away includes about 20 paid vacation days, paid holidays, personal days, and a year‑end shutdown. A paid six‑week sabbatical every six years notably expands long‑term time‑off flexibility.
Genentech Insights
What We Do
Considered the founder of the industry, Genentech, now a member of the Roche Group, has been delivering on the promise of biotechnology for more than 40 years. Genentech is a biotechnology company dedicated to pursuing groundbreaking science to discover and develop medicines for people with serious and life-threatening diseases. Our transformational discoveries include the first targeted antibody for cancer and the first medicine for primary progressive multiple sclerosis. We're passionate about finding solutions for people facing the world's most difficult-to-treat conditions. That is why we use cutting-edge science to create and deliver innovative medicines around the globe. To us, science is personal. Making a difference in the lives of millions starts when you make a change in yours.
