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

• Receive, verify, and inspect incoming GMP raw materials against purchase orders, specifications, and vendor documentation (e.g., CoA, CoC).
• Confirm vendor/manufacturer part numbers, lot numbers, and material descriptions to ensure full alignment with approved raw material specifications.
• Perform visual inspection of material containers for integrity, damage, or nonconformance.
• Print, prepare, and apply raw material quarantine identification labels according to SOP requirements.
• Verify critical specification attributes including storage conditions, expiration or retest dates, and vendor information.
• Sample raw materials per approved sampling SOPs and coordinate submission to QC laboratories.
• Maintain accurate records in the IQA Raw Material History Log, including lot number, receipt date, quantities, and expiration dates.
• Ensure correct storage and quarantine of raw materials under appropriate environmental conditions (temperature, light protection, etc.).
• Record all inspection and verification results in the raw material specification packet.
• Notify Quality Assurance and Materials Management of discrepancies or documentation issues.
• Support material disposition activities in accordance with internal quality procedures.
• Collaborate cross-functionally with QA, QC, and Materials Management to ensure timely availability of compliant raw materials.
• Utilize ERP systems (e.g., Oracle Fusion) to support material tracking, status updates, and transaction logging.
• Follow all applicable GMP, safety, and compliance regulations.

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.
• Ability to lift and move raw material containers as needed (typically up to 40 lbs).

EDUCATION & EXPERIENCE:

• Bachelor’s degree in a scientific discipline (Chemistry, Biology, Biochemistry, Engineering, or related field) preferred; equivalent industry experience considered.
• 1–3 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.