Sr. QC Associate (LIMS, Equipment Validation)

Are you ready to take the next step in your career and join a groundbreaking team at Genentech? We are looking for a motivated and skilled Senior QC Associate with a deep understanding of quality control systems, lab equipment validation, and GMP compliance to support our dynamic Quality Control (QC) organization in Oceanside, California.

In this role, you will serve as a key point of contact and subject matter expert for QC systems (e.g., LIMS, Empower, Biovia) and lab equipment, ensuring smooth operations and compliance with industry standards. Your expertise will be essential in creating, reviewing, and approving validation documents, identifying and resolving equipment and process issues, and providing hands-on training and guidance to QC teams. As the go-to liaison with IT and cross-functional teams, you'll drive impactful projects to support daily laboratory operations and maintain the validation program for analytical instruments.

If you're passionate about applying advanced troubleshooting techniques, leading initiatives in quality compliance, and serving as a subject matter expert on critical QC systems and processes, this opportunity is for you.

The Opportunity

• Represents QC as a subject matter expert during audits by presenting data, validations, and other technical information.

• Compiles data for documentation of test procedures and prepares reports for internal and regulatory submissions.

• Reviews and evaluates data for conformance to specifications/reports.

• Initiates, compiles, and performs lab investigations including reviewing documents and conducting interviews.

• Identifies process improvements for laboratory systems and technical equipment.

• Represents organization on assigned projects.

• Applies a complete understanding of theories and concepts from one's discipline to independently address a broad range of difficult problems.

• Ensures the integration of environmental health, safety, and security into the business processes, systems, and programs while reporting safety and environmental incidents including injuries, illnesses, and safety suggestions within one's functional area. Fosters a positive safety culture in which no one gets hurt.

• All employees with jobs that require access to the Warehouse must be able to pass the Transportation Security Administration (TSA) Security Threat Assessment (STA).

Who you are

Education & Experience

• Bachelor's Degree in a relevant scientific discipline.

• 7-8 years of related experience.

• Minimum of 3 years experience in Quality Control.

• Preferred experience using computer laboratory information management systems.

Knowledge, Skills, and Abilities

• Demonstrates excellent organizational, written, and verbal communication skills.

• Demonstrate excellent interpersonal skills including the ability to resolve conflicts with poise, diplomacy and tact. Work effectively as part of a team and collaborate with staff at all levels.

• Knowledge of computer-based systems, including LIMS, and experience with electronic systems used in laboratories.

• Strong knowledge of Quality Control, GMPs, Health Authority Regulations, and validation practices/principles.

• Ability to work under limited direction and guidance, and effectively prioritize with appropriate urgency to meet timelines.

• Ability to troubleshoot technical data and use discretion and good judgment in making decisions.

• Experience speaking to auditors and acting as a subject matter expert.

Work Environment/Physical Demands/Safety Considerations

• Works in office and laboratory environment.

• May be required to lift up to 30lbs.

• On occasion may work in a clean room environment that requires gowning.

• May be exposed to hazardous materials and chemicals.

• Ability to sit, stand, and move within the workspace for extended periods.

• May be required to work some evenings and weekends.

Relocation benefits are available for this posting

The expected salary range for this position based on the primary location of California is $68,300 (min) - $97,600 (mid) - $126,900 (max). 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.