Quality Control Associate II

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PAC-QC is one of the four departments that comprises Analytical Development and Quality Control (ADQC) organization within Pharma Technical Development, US (PTDU).

As a GMP department, PAC-QC is responsible for implementation of control system for IMP biologics, managing the characterization and extension of expiry of Reference Standards, authoring/reviewing the QC related sections of INDs/CTAs and BLA filings, release and stability testing of IMP products, and QC operations supporting the GMP functions in ADQC and partially gRED.

The Opportunity

This role will support multi-disciplinary teams within PAC-QC utilizing expertise of various Roche Quality Systems that create, build, implement, monitor, and sustain Laboratory Information Management and Change Management programs. As a member, the QC Associate is responsible for providing GMP data management systems support for global systems used within Quality Control.

What You'll Do

You are responsible for ensuring data management activities are executed through an approved Technical Change Control Management process in addition to non-critical data object maintenance through the ServiceNow IT ticket management process. You will also be involved complex data mapping and troubleshooting, as needed.

As a member of this team, you will also be responsible for executing clinical change records utilizing quality systems (e.g, Veeva) for New Product Introductions, QC Sampling Plans, Product Acceptance Requirement documents, Test Procedures, Product Expiry memos, Reference Standard programs, and Stability protocols. This effort involves close collaboration with Quality Assurance, Regulatory, QC Technical Managers, Method Validation managers, Scientists, and QC end-users to effectively support time sensitive campaigns for drug substance production and drug product fills.

You will support the QC equipment qualification team and will involve drafting and managing the IQ/OQ/PQ protocol and report workflows in the Veeva EDMS system and tracking/managing equipment calibration to ensure equipment is suitable for routine use.

You must have process knowledge and experience in QC operations and will be involved to ensure that all aspects of the life cycle control system across Genentech's clinical product portfolio and testing sites (including Clinical Manufacturing Organizations and partners) are properly executed with timeliness and compliance.

Who You Are

• You have a BS/BA in chemistry, biochemistry, biology or related discipline with at least 3 years' experience, or M.S, with at least 2 years' experience in a GMP environment, preferably with direct QC and GMP systems experience.

• You are highly motivated and self-driven

• You have excellent verbal and written communication skills, in addition to strong interpersonal skills

• You have a demonstrated proficiency with Veeva EDMS and Planned Events, LIMS, ELNs, and SAP is (a plus).

The expected salary range for this position based on the primary location of South San Francisco, CA is $78,500 - $145,900. 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.

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