QC Sr. Associate I (Software Developer Specialist) Fixed Term
Oceanside, CA - USA
Job Summary
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 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: Bachelors degree with 811 years of experience a Masters degree with 69 years of experience or a PhD with 36 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 $90100 - $167300. 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 companys 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.
Required Experience:
Senior IC
About Company
As a pioneer in healthcare, we have been committed to improving lives since the company was founded in 1896 in Basel, Switzerland. Today, Roche creates innovative medicines and diagnostic tests that help millions of patients globally.