QC Sr. Associate ; Software Developer Specialist
Listed on 2026-07-21
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Business
Regulatory Compliance Specialist
Position
QC Senior Associate I (Software Developer Specialist)
Role OverviewThis role is a valuable part of our Quality Control team, committed to ensuring data integrity, compliance, and operational excellence across 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 to optimize laboratory processes. Together, we ensure our systems meet stringent regulatory standards while maximizing efficiency to deliver life‑saving therapies safely to patients.
Key Responsibilities- Develop automated workflows and "recipes" within the Biovia software system to support laboratory operations.
- Partner with business stakeholders and end‑users to gather feedback, translate business requirements, and propose new functionalities or system enhancements.
- Detect, report, and document software defects; test new features and support continuous system improvements.
- Design and enhance user interfaces and data reporting functionalities within laboratory informatics systems.
- Prepare and maintain detailed technical documentation and validation records following Good Documentation Practices in a regulated pharmaceutical environment.
- Support the integration and functionality of laboratory software and systems such as LIMS, ELN/LES, and computerized analytical instruments.
- Education:
Bachelor’s degree with 8–11 years of experience, Master’s degree with 6–9 years of experience, or PhD with 3–6 years of experience in Computer Science, Life Sciences, or an equivalent combination. - Industry
Experience:
Minimum of 8 years of pharmaceutical industry experience, with at least 5 years focused on Software Development or Quality Control. - Technical skills:
Expert knowledge of computer‑based systems with emphasis on the Biovia Software System and familiarity with BPMN fundamentals and workflow design. - Domain knowledge:
Solid understanding of biotechnology, biochemistry, microbiology, or analytical chemistry, coupled with strong knowledge 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. - Project execution:
Demonstrated ability to work under limited direction, establish priorities, manage timelines, and coordinate multiple projects independently. - Communication and interpersonal skills:
Strong verbal and written communication skills with the ability to resolve conflicts diplomatically and collaborate across international teams and with external vendors or regulatory agencies.
This is an on‑site position. Relocation benefits are not available.
The expected salary range for this position based on the primary location of California is $90,100 - $167,300. Salary 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.
Equal Opportunity StatementGenentech 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, 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.
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