QC Specialist II

Germer International - Pharmaceutical Recruiting; Harmonville (PA); On-site; USD 85,000 - 120,000; Full time

Job summary

Germer International - Pharmaceutical Recruiting seeks a QC Specialist II to support quality control testing for cell and gene therapy products in a GMP environment. Hands-on expert in cell-based immunology assays and flow cytometry is essential.

Role involves ensuring data integrity, coordinating with QC, QA, Manufacturing, and Analytical Development to maintain timelines and product quality for releases and stability programs.

Qualifications

• Bachelor's degree in Biology or related discipline.
• At least 5 years in cell/gene therapy or GMP biologics environments.
• Hands-on in cell-based immunology assays and flow cytometry.
• Knowledge of cGMP, data integrity, and analytical acceptance criteria.
• Experience with LIMS and electronic quality management systems.

Responsibilities

• Perform routine and non-routine QC testing to support manufacturing, product release, and stability programs.
• Execute cell-based immunology assays, including activation, cytokine, immune-function, and potency assays.
• Perform flow cytometry testing, including staining, acquisition, compensation, gating, and data interpretation.
• Test in-process samples, drug substance, drug product, raw materials, and stability samples against methods.
• Operate and troubleshoot laboratory instrumentation and data software.
• Review data, controls, calculations, and acceptance criteria for accuracy.
• Maintain GMP-compliant documentation and support investigations, deviations, OOS/OOT, CAPAs.
• Utilize LIMS and electronic quality systems to manage samples and quality records.
• Support analytical method transfers, troubleshooting, qualification, validation, and improvement.
• Partner with QC, QA, Manufacturing, and Analytical Development to meet timelines.

Skills

Cell-based immunology

Flow cytometry

GMP compliance

Data analysis

LIMS

Education

Bachelor's degree in Biology or related

Tools

LIMS

Data analysis software

Flow cytometer hardware

Job description

We’re seeking a QC Specialist II to support quality control testing for cell and gene therapy products, viral vectors, and related materials. This role is ideal for a hands‑on laboratory professional with experience in GMP-regulated environments and technical expertise in cell‑based immunology assays, potency testing, and flow cytometry.

Key Responsibilities

• Perform routine and non‑routine QC testing to support manufacturing, product release, and stability programs.
• Execute cell‑based immunology assays, including cellular activation, cytokine, immune‑function, and functional potency assays.
• Perform flow cytometry testing, including sample preparation, staining, acquisition, compensation, gating, and data interpretation.
• Test in‑process samples, drug substance, drug product, raw materials, and stability samples against approved methods and specifications.
• Operate and troubleshoot laboratory instrumentation and associated data acquisition and analysis software.
• Review analytical data, assay controls, calculations, and acceptance criteria to ensure accurate and reliable results.
• Maintain GMP‑compliant documentation and support laboratory investigations, deviations, OOS/OOT assessments, root cause analysis, and CAPAs.
• Utilize LIMS and electronic quality management systems to manage samples, results, controlled documents, and quality records.
• Support analytical method transfers, troubleshooting, qualification, validation, and continuous improvement initiatives.
• Partner with QC, QA, Manufacturing, and Analytical Development to maintain testing timelines and product quality.

Required Qualifications

• Bachelor's degree in Biology, Cell Biology, Immunology, Biotechnology, Biochemistry, Molecular Biology, Biomedical Sciences, or a related discipline.
• Minimum of 5 years of relevant industry experience in cell and gene therapy, viral vector manufacturing, or a comparable GMP‑regulated biologics environment.
• Hands‑on experience with cell‑based immunology assays, potency assays, and flow cytometry, including multicolor analysis, compensation, gating strategies, and assay controls.
• Working knowledge of cGMP requirements, laboratory documentation, data integrity principles, and analytical acceptance criteria.
• Experience with laboratory instrumentation, data analysis platforms, LIMS, and electronic quality management systems.
• Ability to troubleshoot analytical methods, interpret results, identify atypical findings, and manage competing priorities in a fast‑paced laboratory environment.