QC Analyst III, Analytical - Large Scale Allogenic Manufacturing

What you'll do

• Advanced cGMP Release Testing: Execute complex biological, immunological, and cell-based testing—specifically utilizing flow cytometry, ELISA, PCR assays, cell culture, and cell counting—ensuring total compliance with internal SOPs, USP, and EP guidelines to support on-time in-process control and final product release.
• Assay Transfer & Method Validation: Actively spearhead analytical method transfers, qualifications, and validation protocols, including onboarding new methodologies and configuring advanced laboratory instrumentation.
• Data Review & Verification: Review raw laboratory records, data calculations, and execution logs for absolute accuracy, protocol compliance, and strict adherence to Good Documentation Practices (GDP).
• Investigation & OOS Ownership: Lead comprehensive Out-of-Specification (OOS) and laboratory deviation investigations, leveraging root-cause analysis tools to address complex non-conformances with minimal support.
• CAPA & Change Control Management: Author, edit, and coordinate corrective and preventive actions (CAPAs) and detail structured Change Controls to promote compliance and continuous laboratory improvement with minimal support.
• Document Architecture: Develop, modify, and sustain standard operating procedures (SOPs), master forms, and test records to match evolving industry expectations and site improvements.
• Peer Training & Floor Leadership: Deliver hands-on, on-the-job training for junior QC personnel, reviewing data packets, modeling strong work ethics, and escalating critical laboratory anomalies to management as needed.

What we're looking for

• Experience: 3-4+ years of direct Quality Control laboratory experience within a cGMP biomanufacturing or regulated clinical testing setting is required.
• Technical Mastery: Proven, hands-on experience performing cell culture maintenance, immunophenotyping panels via flow cytometry, PCR amplification, and standard immunological assay techniques.
• Systems & Digital Compliance: Familiarity with Laboratory Information Management Systems (LIMS), enterprise data management applications, and quality systems software (such as TrackWise) is highly preferred.
• Investigation Savvy: Demonstrated ability to independently lead laboratory event investigations, formulate root-cause theories, and write clear, logical technical summaries.
• Education: Bachelor's Degree in Biochemistry, Biology, or a closely related technical science discipline is required. A Master's Degree in a scientific discipline is preferred.
• Soft Skills: Superior written and oral communication skills, a solutions-focused team attitude, and the personal initiative required to navigate multiple testing demands and overcome performance roadblocks without routine reminders.