Sr. QC Associate (LIMS, Equipment Validation)

GenentechOceanside, CA
110d$68,300 - $126,900

About The Position

Are you ready to take the next step in your career and join a groundbreaking team at Genentech? We are looking for a motivated and skilled Senior QC Associate with a deep understanding of quality control systems, lab equipment validation, and GMP compliance to support our dynamic Quality Control (QC) organization in Oceanside, California. In this role, you will serve as a key point of contact and subject matter expert for QC systems (e.g., LIMS, Empower, Biovia) and lab equipment, ensuring smooth operations and compliance with industry standards. Your expertise will be essential in creating, reviewing, and approving validation documents, identifying and resolving equipment and process issues, and providing hands-on training and guidance to QC teams. As the go-to liaison with IT and cross-functional teams, you'll drive impactful projects to support daily laboratory operations and maintain the validation program for analytical instruments. If you're passionate about applying advanced troubleshooting techniques, leading initiatives in quality compliance, and serving as a subject matter expert on critical QC systems and processes, this opportunity is for you.

Requirements

  • Bachelor's Degree in a relevant scientific discipline.
  • 7-8 years of related experience.
  • Minimum of 3 years experience in Quality Control.
  • Preferred experience using computer laboratory information management systems.
  • Demonstrates excellent organizational, written, and verbal communication skills.
  • Demonstrate excellent interpersonal skills including the ability to resolve conflicts with poise, diplomacy and tact.
  • Knowledge of computer-based systems, including LIMS, and experience with electronic systems used in laboratories.
  • Strong knowledge of Quality Control, GMPs, Health Authority Regulations, and validation practices/principles.
  • Ability to work under limited direction and guidance, and effectively prioritize with appropriate urgency to meet timelines.
  • Ability to troubleshoot technical data and use discretion and good judgment in making decisions.
  • Experience speaking to auditors and acting as a subject matter expert.

Responsibilities

  • Represents QC as a subject matter expert during audits by presenting data, validations, and other technical information.
  • Compiles data for documentation of test procedures and prepares reports for internal and regulatory submissions.
  • Reviews and evaluates data for conformance to specifications/reports.
  • Initiates, compiles, and performs lab investigations including reviewing documents and conducting interviews.
  • Identifies process improvements for laboratory systems and technical equipment.
  • Represents organization on assigned projects.
  • Applies a complete understanding of theories and concepts from one's discipline to independently address a broad range of difficult problems.
  • Ensures the integration of environmental health, safety, and security into the business processes, systems, and programs while reporting safety and environmental incidents including injuries, illnesses, and safety suggestions within one's functional area.
  • Fosters a positive safety culture in which no one gets hurt.

Benefits

  • Relocation benefits are available for this posting.
  • A discretionary annual bonus may be available based on individual and Company performance.

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What This Job Offers

Job Type

Full-time

Career Level

Senior

Industry

Chemical Manufacturing

Education Level

Bachelor's degree

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