About the job
Senior Lead Analyst, Quality Control Analytical | GMP | HPLC
Job Overview:
The Senior Lead Analyst in Analytical Quality Control is a pivotal role that serves as a technical authority in intricate analytical testing and instrumentation. This position encompasses leadership, mentorship, and project management responsibilities to ensure quality control operations align with cGMP standards.
As a key individual contributor, you will bridge your advanced technical expertise with leadership duties, safeguarding product quality, regulatory compliance, and data integrity within a biopharmaceutical manufacturing setting.
- Reports To: Associate Director, Quality Control Analytical
- Location: Newark, CA
- Compensation Range: $115,000 - $130,000 + Bonus * Final salary depends on factors like experience, education, and geographic location.
Key Responsibilities:
- Analytical Testing: Conducting and reviewing sophisticated analytical tests on raw materials, in-process samples, and finished products employing techniques such as HPLC, UPLC, LCMS, ELISA, and CE-SDS among various compendial methods.
- Documentation and Compliance: Drafting, reviewing, and approving GMP documentation including SOPs, test methodologies, protocols, technical reports, and quality records (deviations, OOS, CAPAs, Change Controls), ensuring strict adherence to cGMP, GLP, ICH, FDA, and EMA guidelines.
- Troubleshooting and Investigation: Acting as a subject matter expert to resolve complex equipment and method-related issues while leading comprehensive investigations into out-of-specification (OOS) or out-of-trend (OOT) results through root cause analysis techniques.
- Method Lifecycle Management: Overseeing and supporting the development, optimization, transfer, qualification, and validation of analytical methods for both new and existing products.
- Leadership and Training: Providing mentorship and training to junior analysts, guiding the team in laboratory processes, and potentially managing daily activities and resource distribution.
- Project Collaboration: Engaging with cross-functional teams to ensure alignment on project objectives and deliverables.

