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Senior Quality Control (QC) Analyst at ZYLIDAC BIO LLC – Emeryville, California

ZYLIDAC BIO LLC
Emeryville, California, 94608, United States
Posted on
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Recently UpdatedSalary:$80000 - $100000Job Function:Information Technology

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About This Position

Description:
  • Perform in-process, release, and stability testing of GMP samples using HPLC/UPLC platforms, residual ELISAs, and other qualified analytical assays.
  • Execute analytical testing strictly per validated/qualified methods and SOPs.
  • Independently perform complex analytical assays and support laboratory investigations with minimal supervision
  • Lead and support analytical development activities and nonclinical sample testing for IND-enabling and CMC/BLA programs.
  • Author, revise, qualify, and validate analytical test methods in alignment with ICH guidelines and internal quality standards.
  • Document deviations, support root-cause investigation, and contribute to CAPA implementation.
  • Maintain laboratory operations by managing inventory, preparing reagents and reference standards, and ensuring safe and compliant workflows.
  • Ensure equipment readiness by performing routine maintenance, monitoring calibration, and coordinating service as needed.
  • Provide peer review of GMP data packages and validation documentation.
  • Train, mentor, and provide technical guidance to junior QC Analysts.
  • Maintain complete and contemporaneous GMP documentation to support data integrity.
  • Support regulatory inspections, audits, and client interactions.
  • Participate in continuous improvement initiatives to enhance QC efficiency, compliance, and technical robustness.
Requirements:
  • Minimum 3-5 years of hands-on QC Chemistry laboratory experience in a GMP-regulated environment
  • Strong working knowledge of cGMP regulations, data integrity, and applicable ICH/USP analytical guidelines.
  • Demonstrated experience with method development, validation, qualification, and transfer.
  • Proven ability to independently troubleshoot complex analytical assays and resolve instrumentation or method-related issues.
  • Strong attention to detail and a high level of accuracy in data generation, documentation, and review under GMP guidelines.
  • Excellent oral and written communication skills.
  • Strong problem-solving aptitude with the ability to identify root causes and support effective corrective actions.
  • Demonstrated ability to work both independently and collaboratively within a small, high-performing QC team.
  • High motivation to meet the operational and compliance demands of the QC department and cross-functional partners.
  • Experience supporting regulatory audits, QA inspections, or client audits is desirable.
  • Bachelor’s degree in a scientific discipline with 3–5 years of experience in a GMP/QC environment, or Master’s degree in a scientific discipline with 1–3 years of experience in a GMP/QC environment.

Job Location

Emeryville, California, 94608, United States

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