QA Specialist/Sr. QA Specialist

A healthier future. It's what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That's what makes us Roche.

This role is based in the Pharmaceutical Technology SSF Quality Assurance division which is dedicated to providing world-class biological products for patients. The role is a critical member of the Quality Product Review and Release (QPR&R) team. The QPR&R team spans synchronous DP production floor oversight including recipe & ticket approvals, incoming and direct material releases, assay history review and CoA generation, product release, and Quality Single Point of Contact (QSPOC) for products ranging from early NMEs through PhIII and commercial products in new indication trials.

Our roles have an immediate link to product quality and patient safety. Our team members' care and diligence is a direct reflection of that patient connection. The outstanding variety of Quality accountabilities applied in this team offers you great learning opportunities.

As a critical role in the QPR&R team, your main focus will be supporting the management of Direct Material releases and Certificate of Analysis generation.

• You are making informed and independent decisions on complex issues in collaboration with key stakeholders and alignment with Roche/Genentech policies.

• You lead or participate on interdepartmental/global teams, process improvements, and new process design.

• You perform thorough evaluations of raw materials and in-process items for the timely and accurate release of these materials for production based on established quality standards and test results.

• You conduct comprehensive reviews of assay histories to confirm all test results are accurate and complete.

• You hold Bachelor's degree in Life Sciences, Engineering, or a related field.

• You have 5+ years of experience in the pharmaceutical industry.

• You have knowledge of manufacturing data, QC data, computerized systems, laboratory testing and test methods, GMP records.

• You have a proven ability to successfully collaborate on site initiatives while managing daily responsibilities and meeting deadlines.

Preferred:

• Understanding biological clinical product development process, especially about the analytical method development, validation, and testing, is strongly preferred

• Experience with Veeva (QMS), S4/HANA P1S SAP, BRH, Single LIMS, GLAS/MDMS

Relocation benefits are not available for this posting

The expected salary range for this position based on the primary location of South San Francisco California is $108,100 - $200,700. 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

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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.

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