Quality Control (QC) Analyst

Key Accountabilities/ Core Job Responsibilities:

• Executes routine and ad hoc analytical testing of raw materials, drug substance, and drug product using chromatographic and electrophoretic methods in accordance with approved test methods and procedures.
• Performs chromatography-based assays including SEC, Reverse Phase HPLC (titer), icIEF, CE-SDS, and glycan/sialic acid analyses for large molecule programs.
• Participates in the validation, transfer, and implementation of USP/EP and product-specific analytical methods by executing protocol testing under the direction of senior QC staff.
• Performs stability testing of drug substance and drug product at required timepoints and storage conditions.
• Generates, processes, and reports analytical data with accuracy and in compliance with data integrity requirements; escalates atypical or unexpected results promptly.
• Supports QC-Chemistry investigations and quality events, including deviations, LIR/OOS, CAPA, and change controls, by providing accurate laboratory documentation, data, and observations; initiates LIR/OOS records when required.
• Works within LabWare LIMS for sample login, method execution, and result entry.
• Assists with review of analytical documentation for product disposition.
• Helps to draft risk assessments, protocols, methods, and any other QC documentation as needed.
• Collaborates with Analytical Development, Manufacturing, and Quality teams during method validation/transfer and assay troubleshooting.
• Prepares reagents, buffers, mobile phases, and reference standard solutions; performs routine instrument checks, preventive maintenance, and calibration verification; maintains laboratory supplies and sample inventory.
• Completes required training and maintains training records current in accordance with site procedures.
• Works with accuracy, urgency, and a continuous improvement mindset and provides flexible support.

Qualifications/Skills:

• Typically requires a BS in Chemistry, Biology, Biochemistry, or a related scientific discipline with 4+ years of experience in a GMP-regulated laboratory, including hands-on chromatography (HPLC/UPLC) experience; large molecule/biologics experience preferred.
• Working knowledge of GMP regulations and familiarity with current USP/Ph. Eur., FDA, and ISO standards and guidance.
• Ability to follow established procedures with attention to detail and a right-first-time approach; developing ability to work independently with general supervision.
• Effective written and verbal communication skills and the ability to build productive working relationships with internal teams.
• Experience with LIMS and electronic quality management systems required; LabWare LIMS, MasterControl, and Waters empower experience preferred.
• Ability to meet laboratory physical requirements, including specialized gowning, lifting and manipulating items greater than 25 lbs, climbing ladders, and standing for extended periods.