QC Sr. Associate I (Software Developer Specialist) - Fixed Term

Genentech; Oceanside (CA); On-site; USD 90,100 - 167,300; Full time

Job summary

Genentech in California is seeking a QC Senior Associate I (Software Developer Specialist) to drive automation of digital laboratory processes within a GMP environment. You will design, create, and modify automated workflows and Biovia recipes, bridging laboratory science with informatics to ensure data integrity and compliant operations.

Collaborating with Quality Control, Validation, and end-users, you will test features, troubleshoot defects, and enhance reporting interfaces while maintaining

Qualifications

• Bachelor’s or higher in CS or Life Sciences with required years of experience.
• Pharma industry experience (8+ yrs); 5+ yrs in software development or QC.
• Strong knowledge of Biovia, BPMN, cGMP, data integrity, and validation principles.

Responsibilities

• Develop Automated Workflows: Design, create, and modify complex laboratory workflows and automated recipes within the Biovia system.
• Cross-Functional Collaboration: Partner with stakeholders to gather feedback and propose enhancements.
• System Testing & Troubleshooting: Detect, report, and document defects, test features, and support improvements.
• Optimize Reporting & Interfaces: Design and enhance user interfaces and data reporting in informatics systems.
• Maintain Compliance Documentation: Prepare and maintain GDP-compliant documentation and validation records.
• Interface with Informatics Systems: Support integration of laboratory software and systems (LIMS, ELN/LES).

Skills

Biovia Software System

BPMN workflow design

Data integrity concepts

cGMP regulations

Analytical chemistry techniques

Regulatory audits

Independent project execution

Communication skills

Education

Bachelor’s degree in Computer Science or Life Sciences

Master’s degree in related field

PhD in related field

Tools

Biovia Software System

LIMS

ELN/LES

Job description

The Position

This role is a valuable part of our Quality Control team, which is committed to ensuring data integrity, compliance, and operational excellence across our laboratory workflows. As a member of this team, you will bridge the gap between laboratory sciences and digital automation by developing specialized software configurations and automated workflows. You will have the opportunity to collaborate closely with key stakeholders across Quality Control, Validation, and end-users to optimize laboratory processes. Together, we ensure our systems meet stringent regulatory standards while maximizing efficiency to deliver life‑saving therapies safely to patients.

The Opportunity

As a QC Senior Associate I (Software Developer Specialist), you will drive the automation and optimization of digital laboratory processes by designing, creating, and modifying automated workflows and "recipes" within the Biovia software system. In this role, you will bridge the gap between technical software functionality and day‑to‑day Quality Control laboratory operations to ensure seamless data integrity and compliance in a regulated GMP environment.

• Develop Automated Workflows: Design, create, and modify complex laboratory workflows and automated "recipes" specifically within the Biovia software system.
• Cross‑Functional Collaboration: Partner with business stakeholders and end‑users to gather feedback, translate business requirements, and propose new functionalities or system enhancements.
• System Testing & Troubleshooting: Detect, report, and document software defects, test new features, and support continuous system improvements.
• Optimize Reporting & Interfaces: Design and enhance user interfaces and data reporting functionalities within laboratory informatics systems.
• Maintain Compliance Documentation: Prepare and maintain detailed technical documentation and validation records following Good Documentation Practices (GDP) in a highly regulated pharmaceutical environment.
• Interface with Informatics Systems: Support the integration and functionality of laboratory software and systems such as LIMS, ELN/LES, and computerized analytical instruments.

Who You Are

Education & Experience

• Educational Background: Bachelor’s degree with 8–11 years of experience, a Master’s degree with 6–9 years of experience, or a PhD with 3–6 years of experience in Computer Science (Software Development), Life Sciences (Biology, Biochemistry), or an equivalent combination of education and experience.
• Industry Experience: Minimum of 8 years of pharmaceutical industry experience, with at least 5 years specifically focused in a Software Development or Quality Control role.

Technical & Soft Skills

• Software System Expertise: Expert knowledge of computer‑based systems, with an emphasis on the Biovia Software System, alongside familiarity with BPMN fundamentals and workflow design.
• Domain & Regulatory Knowledge: Solid domain knowledge in biotechnology, biochemistry, microbiology, or analytical chemistry, coupled with a strong understanding of cGMP regulations, Data Integrity concepts, and validation principles.
• Analytical Techniques: Familiarity with regulated laboratory environments and common laboratory techniques such as chromatography, spectrometry, coulometry, or particle analysis.
• Independent Project Execution: Demonstrated ability to work under limited direction, establish personal work priorities, manage timelines, and independently coordinate multiple projects.
• Communication & Interpersonal Skills: Strong verbal and written communication skills, with the ability to resolve conflicts with diplomacy and tact while collaborating effectively across international teams and with external vendors or regulatory agencies.

This is an on‑site position.

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. 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 in this link.

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.