QC Analyst II - Cell Therapy
Lonza · Portsmouth, NH · 2 wk ago
Quality AssuranceFull-time
About the role
As a QC Analyst II on our Cell Therapy Analytical team, you are a vital link in the chain of patient care. You will perform high-precision testing such as Flow Cytometry and Molecular assays that confirms the safety and potency of personalized medicines. This role is designed for a detail-oriented scientist who is ready to take more ownership of laboratory operations and provide reliable, high-quality data in a fast-paced environment that bridges the gap between our day and night operations.
Responsibilities
- Analytical Execution: Perform complex analytical assays to support in-process, lot release, and stability testing.
- Aseptic Excellence: Maintain the highest standards of sterility when handling sensitive human biological samples to ensure 100% data integrity and prevent contamination.
- Data & Compliance: Document results in real-time following Good Documentation Practices (GDP).
- Problem Solving & Investigations: Identify and escalate results that deviate from expected ranges. Assist senior analysts and supervisors in "root cause" investigations when technical variances occur.
- Lab Stewardship: Support the lifecycle of the lab by assisting with equipment qualifications, reagent preparation, and the maintenance of a safe, cGMP-compliant workspace.
- Shift Synergy: Act as a critical communication bridge between day and night operations, ensuring seamless handovers to maintain production momentum.
Requirements
- Experience: 1–2 years of experience in a regulated lab environment (GMP/GLP).
- Education: Associate’s or Bachelor’s degree in a Scientific Discipline (Biology, Microbiology, Biochemistry, or related field) is required.
- Technical Aptitude: Familiarity with laboratory computer systems (LIMS) and a strong desire to master complex analytical instrumentation.
- Shift: Ability to consistently work the 2nd Shift, 11:00 AM – 9:30 PM, Sunday-Wednesday Schedule.
- Attention to Detail: An uncompromising commitment to following Standard Operating Procedures (SOPs) and maintaining meticulous records.
Qualifications
- Recent college graduates with exceptional technical aptitude in their academic labs and eager to launch their careers in a fast-paced industrial setting are also highly considered.
Skills
- Advanced Technical Mastery: Refine your expertise in cutting-edge analytical techniques (Flow Cytometry, ELISA, qPCR) used in the release of world-class cell-based therapies.
Benefits
- Full Lonza Benefits: Medical, dental, vision, 401(k), and performance-based incentives.