QC Analyst, Quality Control Laboratory

Overview:

This laboratory position will be in the Quality Control Department and support activities associated with routine in-process testing, Certificate of Analysis (COA) release testing, and stability program support for biologics. This position will demonstrate strong technical proficiency with analytical methods, operate as a technical leader within the QC team, supporting complex testing, driving investigation quality, and ensuring compliant execution of analytical programs.

In addition, this position will support laboratory investigations, identify and help implement CAPAs, and participate in analytical method lifecycle activities including protocol drafting and execution of method validation, verification, and transfer in accordance with regulatory expectations.

Responsibilities:

• Perform and review routine in-process, release, and stability testing for biologic drug substances and drug products while adhering to GMP/GDP QC requirements
• Experience performing plate-based ELISA, ligand binding assays required
• Execute and troubleshoot a range of analytical methods including HPLC/UPLC (SEC, RP, CEX, Peptide Mapping), capillary electrophoresis testing (cIEF, CE-SDS)
• Perform compendial methods relevant to large molecule therapeutics (USP/EP/JP)
• Support laboratory investigations, including OOS, OOT, and atypical result investigations
• Conduct root cause analysis and identify, implement, and verify effectiveness of CAPAs
• Draft and oversee protocols for method validation, verification, and transfer
• Interpret results, perform statistical analyses, and prepare validation reports aligned to ICH Q2 and US FDA expectations
• Author and review SOPs, test methods, protocols, and technical reports
• Ensure all work is performed in compliance with cGMP, data integrity principles, and internal QA/QC policies
• Support regulatory inspections and audits as a subject matter expert
• Maintain departmental instruments and ensure timely execution of QC quality system records
• Mentor team members and oversee analytical workflows to meet project goals

Qualifications:

• Bachelor’s or Master’s in Biology, Chemistry, Biochemistry, or a related scientific field.
• Minimum of 3 years of direct, hands-on QC experience in a GMP Quality Control laboratory supporting biologics.
• Technical proficiency with HPLC, ELISA, capillary electrophoresis, and compendial testing.
• Background in laboratory investigations, OOS management, and CAPA implementation.
• Hands-on QC experience with method validation aligned to ICH Q2 and US FDA regulations.
• Excellent technical writing, documentation, and analytical troubleshooting skills.
• Ability to work independently while collaborating effectively across QC, QA, and Regulatory.
• Experience in a commercial-stage or late-phase biologics environment is preferred.
• Familiarity with LIMS and chromatography data systems (e.g., Chromeleon) is highly desirable.
• Strong familiarity with GxP requirements.
• Excellent communication, interpersonal and organizational skills are required.