Senior Quality Control Associate

Lonza•Vacaville, CA

1d•$85,500 - $142,500•Onsite

About The Position

This is a fully site-based role in Vacaville, CA. Working together in person supports close, real-time collaboration and the technical precision needed to manufacture medicines to the highest quality and safety standards. The Senior Quality Control (QC) Associate will act as a team member of the Vacaville Quality Control Product Analytical & Bioassay Testing (PABT) department for testing/release of in-process, drug substance, drug product, and stability testing for customers. The role operates as an experienced individual contributor within QC, accountable for executing work independently within established governance frameworks while collaborating closely with peers and stakeholders to deliver compliant, timely, and sustainable solutions. This role provides subject matter expertise and process ownership for the PABT department and ensures the reliable configuration, operation, and compliance of QC systems that is critical to GMP testing, data integrity, and inspection readiness at the site. Areas of focus include Validation, Information Technology, and Program Management.

Requirements

Bachelor's degree in Life Sciences or a related field.
5-10 years of relevant experience in the pharmaceutical or biopharmaceutical industry.

Nice To Haves

cell based assays
ELISA methods
protein separation assays
molecular biology and analytical chemistry assays
new method development
assay troubleshooting activities
technical writing such as protocol development/authorship, data analysis, and technical report authoring/review/approval
technical trainer and coach for improvements
LIMS
SoftMax Pro (SMP)
EMPOWER
WINKQCL

Responsibilities

Provides subject matter expertise and process ownership for QC methods such as: cell based assays, ELISA methods, protein separation assays, molecular biology and analytical chemistry assays, including new method development and assay troubleshooting activities.
Process owner of moderately complex operational activities; independently diagnoses and resolves complex issues and notifies Senior Management of any potential quality or regulatory compliance issues.
Provides expertise and implements change for PABT methods and QC systems related documentation and procedural activities; technical writing such as protocol development/authorship, data analysis, and technical report authoring/review/approval, as well as the technical trainer and coach for improvements.
Collaborates cross functionally to translate business and laboratory needs into solutions; follow strict safety precautions and laboratory techniques when handling hazardous chemicals and compounds.
Processes deviations, investigations, change records, and CAPAs related to the PABT methods and QC systems, contributing to root cause analysis, technical and risk assessments, and implementation of sustainable corrective/remediation actions.
An SME for audit and inspection activities, preparing documentation, responding to auditor inquiries, and presenting system controls and data flows as required.
Follow strict safety precautions and laboratory techniques when handling hazardous chemicals and compounds.
Owns QC master data configuration and maintenance to ensure accuracy, traceability, and GMP/data integrity compliance across systems including LIMS, SoftMax Pro (SMP), EMPOWER, and WINKQCL.
Deliver timely, accurate, and Right-First-Time system configurations, method validations, and master data management to minimize downstream impact.
Maintain system availability and readiness for QC testing, tech transfers, and routine laboratory operations.
Diagnose and resolve system issues independently using a risk-based approach and root-cause analysis to decrease the issue backlog.
Ensure constant audit and inspection readiness for all method validations, data integrity practices, and system lifecycle documentation.
Partner cross-functionally with QC labs, QA, IT, and Validation while translating technical system requirements for non-technical stakeholders.