Quality Control Raw Material Analyst

Responsibilities

• Perform incoming inspection of raw materials, components, and single-use systems in accordance with approved sampling plans and acceptance criteria (e.g., AQL-based plans per ANSI/ASQ Z1.4)
• Execute material sampling using aseptic or clean techniques as appropriate; prepare and label samples in compliance with chain-of-custody and traceability requirements
• Verify Certificate of Analysis (CoA), Certificate of Conformance (CoC), and other supplier documentation against purchase orders, specifications, and approved supplier qualification records
• Place materials on quarantine hold in the QMS and coordinate with warehouse/materials management for physical segregation
• Coordinate and track material dispositions (approve, reject, conditional release) in the ERP/QMS system
• Prepare sample shipments to external contract testing organizations (CTOs) and internal satellite labs, including proper packaging, temperature monitoring, and regulatory documentation (e.g., IATA compliance for biological or hazardous materials as applicable)
• Maintain sample shipping logs and ensure traceability from sample collection through receipt confirmation at the receiving lab
• Communicate with external testing labs regarding sample receipt, testing timelines, and result delivery; escalate delays or anomalies to the QC Manager
• Perform compendial testing including but not limited to: pH (USP <791>), osmolality, conductivity, appearance/visual inspection (USP <790>), and FTIR (USP <854>)
• Operate and maintain QC instruments; perform instrument calibration checks, cleaning, and basic troubleshooting in accordance with maintenance schedules
• Prepare test solutions, reagents, and standards; verify reagent identity, expiry, and suitability prior to use
• Execute testing per approved test methods and SOPs; record data contemporaneously in batch records, logbooks, or electronic systems
• Review and perform peer verification of raw material test results (CoA, external lab reports, in-house data) against approved specifications prior to disposition
• Identify Out-of-Specification (OOS) and Out-of-Trend (OOT) results; initiate formal investigations in the QMS and participate in root cause analysis as required
• Ensure all raw data, calculations, and documentation meet ALCOA+ data integrity principles
• Author, review, and revise SOPs, work instructions, and forms related to raw material sampling, testing, and inspection activities
• Initiate and participate in deviation investigations and CAPAs associated with raw material or testing nonconformances
• Support change control activities, including assessment of changes to raw material specifications, sampling plans, or testing methods
• Maintain training records and complete all required GMP training in a timely manner; provide hands-on training to qualify new associates in sampling and testing procedures
• Support internal audits and external regulatory inspections; assist with preparation of audit-ready documentation
• Contribute to quality metrics reporting (e.g., raw material rejection rates, testing turnaround times, OOS frequency)

Requirements

• Bachelor's degree in Chemistry, Biology, Pharmaceutical Sciences, or a related science discipline required; comparable experience may be considered
• 2+ years of hands-on experience in a cGMP pharmaceutical, biotech, or CDMO/IDMO environment, with direct experience in raw material or incoming quality control functions preferred
• Working knowledge of USP compendial methods relevant to raw material testing (e.g., <645>, <785>, <790>, <791>, <854>)
• Familiarity with pharmacopeial standards and raw material qualification frameworks (USP, EP, ICH Q3C, ICH Q3D) is a plus
• Experience with AQL-based sampling plans and statistical sampling methodologies preferred
• Prior experience coordinating sample shipments to external CTOs, including documentation and cold-chain logistics, preferred
• Proficiency in electronic QMS, ERP, and/or LIMS systems (e.g., Trackwise, SAP, LabVantage or equivalent)
• Strong attention to detail and commitment to data integrity and contemporaneous documentation
• Excellent written and verbal communication skills; ability to communicate effectively with cross-functional teams and external laboratory contacts
• Must be able to commute to and work on-site in Bridgewater, New Jersey
• Self-awareness, integrity, authenticity, and a growth/entrepreneurial mindset

This is Cellares

Cellares is the first Integrated Development and Manufacturing Organization (IDMO) and takes an Industry 4.0 approach to mass manufacturing the living drugs of the 21st century. The company is both developing and operating integrated technologies for cell therapy manufacturing to accelerate access to life-saving cell therapies. The company’s Cell Shuttle integrates all the technologies required for the entire manufacturing process in a flexible and high-throughput platform that delivers true walk-away, end-to-end automation. Cell Shuttles will be deployed in Cellares’ Smart Factories around the world to meet total patient demand for cell therapies at global scale. Partnering with Cellares enables academics, biotechs, and pharma companies to accelerate drug development and scale out manufacturing, lower process failure rates, lower manufacturing costs, and meet global patient demand. The company is headquartered in South San Francisco, California with its commercial-scale IDMO Smart Factory in Bridgewater, New Jersey. The company is backed by world-class investors and has raised over $355 million in financing.

Leveling will be based on overall experience, education, and demonstration of knowledge throughout the interview process.