Senior Quality Assurance Associate at ZYLIDAC BIO LLC – Emeryville, California

• Review executed paper production drug substance batch records and supporting documentation; perform or support drug substance disposition.
• Provide Quality guidance on documentation discrepancies and compliance concerns.
• Create, revise, and maintain raw material specifications and area-specific SOPs.
• Review raw material inspections and perform raw material release and disposition.
• Update material status and transactions in ERP systems (Oracle / SAP / Oracle Fusion) and associated Excel tracking logs.
• Perform raw material and bulk drug substance quarantine, labeling, and status updates in ERP systems.
• Initiate and manage quality system documentation, including deviations, change controls, CAPAs, and vendor change notifications.
• Ensure compliance with cGMP regulations, ICH guidelines, and corporate and site-specific SOPs and specifications.
• Lead, support, and participate in Quality System and process improvement initiatives.
• Manage retention samples for raw materials, drug substance, and vialed drug product.
• Verify vendor/manufacturer information, including part numbers, lot numbers, material descriptions, and alignment with approved specifications.
• Perform visual inspections of material containers for integrity, damage, or nonconformance.
• Print, prepare, and apply quarantine and identification labels per SOP requirements.
• Verify critical attributes such as storage conditions, expiration/retest dates, and vendor information.
• Maintain accurate records in the IQA Raw Material History Log, including receipt dates, quantities, and expiration dates.
• Ensure proper storage and environmental control of materials (temperature, light protection, etc.).
• Document all inspection and verification results in raw material specification packets.
• Notify Quality Assurance and Materials Management of discrepancies, documentation issues, or nonconformances.
• Collaborate cross-functionally with QA, QC, and Materials Management to ensure timely availability of compliant materials.
• Perform additional duties as assigned while adhering to all GMP, safety, and compliance requirements.

QUALIFICATIONS – SKILLS & REQUIREMENTS:

• Strong understanding of GMP and other quality compliance principles.
• Excellent attention to detail and ability to identify discrepancies in documentation.
• Ability to read and interpret Certificates of Analysis, specifications, and SOPs.
• Strong organizational and time-management skills.
• Effective verbal and written communication skills.
• Ability to work independently while supporting cross-functional team objectives.
• Computer proficiency in ERP systems and standard office software (Excel, Word, Outlook).
• Comfortable working in a controlled environment with chemicals and raw materials while following PPE requirements.

EDUCATION & EXPERIENCE:

• Bachelor’s degree in a scientific discipline (Chemistry, Biology, Biochemistry, Engineering, or related field) preferred; equivalent industry experience considered.
• 3-5 years of experience in GMP manufacturing, quality assurance, quality control, or materials management within the biopharmaceutical or pharmaceutical industry.
• Experience with raw material receipt, sampling, or inspection processes strongly preferred.
• Experience with ERP systems such as Oracle, SAP, or similar platforms is a plus.