QC Sr. Associate I (QC Lab Support LIMS Specialist)

Genentech • Oceanside, CA

7d • $90,100 - $167,300

About The Position

In the QC Sr. Associate I (QC Lab Support LIMS Specialist) role, your primary responsibility is to act as Oceanside QC’s subject matter expert for computer systems such as NextLab, LIMS, SAP, Empower, Tableau etc. In addition, you will perform technical and compliance laboratory related activities that support QC operations. Performs data review; discrepancy and out-of-specification investigation. Leads troubleshooting of assay failures and equipment issues. Supports one or more of the following areas: Microbiology, Bioassays, Adventitious Agents, Product Testing, Stability, Analytical Science and Technology, Validation and Lab Support by applying extensive theoretical and cross-functional expertise in the context of company objectives to independently address complex problems. Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results. Interacts with senior internal and external personnel on significant matters. Represents organization as a prime contact on initiatives and projects. Ensures adherence to and compliance with established company quality policies, practices, SOPs federal regulations. Ensures that Oceanside product(s) consistently meets customer and regulatory requirements by developing, improving, and/or implementing processes, concepts and strategies. May provide direction to employees to schedule, manage and oversee routine activities and initiatives of moderate complexity.

Requirements

• Bachelor’s degree in Life Science (Biology or Biochemistry) or equivalent and a minimum of 5 years of related/relevant experience; or an advanced degree with 3 years of equivalent work experience.
• Minimum 5 years pharmaceutical experience
• Minimum 5 years experience in Quality Control

Responsibilities

• Subject Matter expertise for Computer Systems (e.g., LIMS, SAP, Empower, Tableau Software)
• GMP Compliance & System Management: Ensure GMP computer systems are compliant and fit for intended use; approve major upgrades, replacements, and retirements through change management processes
• Access Control & Data Integrity: Oversee system access procedures including periodic review of user access lists; determine verification methods and propose strategies to achieve better data accuracy
• Issue Management & Communication: Manage escalation of issues to Business or IT; communicate and document status of issues where appropriate; ensure timely quality decisions to meet requirements and timelines
• Validation Strategy & Testing Support: Give input into and help define validation test strategy; provide technical support for analytical, microbiological, and cell-based test methods, control systems, and equipment as needed
• Scientific Problem-Solving & Analysis: Apply advanced theory, technical principles, and expert judgment to address difficult problems; present scientific data and concepts at department, project team, and staff meetings
• Scientific Documentation: Author, review, and approve QC scientific documents including validation project plans, protocols, reports, and annual process monitoring documentation as applicable
• Experimental Design & Implementation: Design and execute experiments to support QC improvement initiatives from proof-of-concept to robust test product and final report
• Equipment & System Maintenance: Manage maintenance of QC equipment including calibration, qualification, and system suitability testing for cGMP activities as applicable
• Quality Reporting & Initiatives: Support QC with quality reports such as Methods Monitoring and Annual Products Review; lead or participate in design and implementation of department and cross-functional initiatives
• Investigation & Regulatory Oversight: Define and direct investigation efforts to maximize efficiency and timely resolution; oversee assembly, review, and approval of scientific and technical reports; interact with and present documentation to regulatory agencies
• Quality Issue Resolution & Stakeholder Management: Facilitate resolution of quality issues affecting product and supply by partnering with key stakeholders; perform high-level interactions across Genentech departments to resolve GMP issues; notify management of potential quality or regulatory issues
• Leadership & Development: Actively coach and mentor staff on a regular basis to ensure high level of technical acumen in QC; may oversee activities of junior-level team members as assigned; work with management to align projects to strategy and business objectives

Benefits

• Relocation benefits are not available for this posting
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior