Senior Quality Control (QC) AnalystZYLIDAC BIO LLC • Emeryville, CA, US
Senior Quality Control (QC) Analyst
ZYLIDAC BIO LLC • Emeryville, CA, US
[job_card.variable_days_ago]
[job_preview.job_type]
- [job_card.full_time]
[job_card.job_description]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 Description
Job Description
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 :
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Senior Quality Control QC Analyst • Emeryville, CA, US
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