Quality Control Analyst

Role:
Quality Control Analyst

Location:
Boston, MA | Onsite

We are seeking a detail‑oriented Quality Control (QC) Analyst with 3+ years of experience in pharmaceutical, biotechnology, or life sciences environments. The ideal candidate will perform analytical testing of raw materials, in‑process samples, finished products, and stability samples while ensuring compliance with GMP regulations and company quality standards.

• Perform routine and non‑routine analytical testing using techniques such as HPLC, UPLC, GC, UV‑Vis, FTIR, TOC, and dissolution.
• Execute testing of raw materials, intermediates, finished products, and stability samples.
• Review and interpret analytical data, ensuring accuracy and compliance with specifications.
• Maintain laboratory documentation, logbooks, and electronic records in accordance with GMP requirements.
• Investigate laboratory deviations, out‑of‑specification (OOS), and out‑of‑trend (OOT) results.
• Support method transfers, method verification, and validation activities.
• Perform instrument calibration, qualification, troubleshooting, and preventive maintenance.
• Participate in internal audits, inspections, and continuous improvement initiatives.
• Collaborate with Manufacturing, Quality Assurance, and Validation teams to resolve quality‑related issues.

• Bachelor's degree in Chemistry, Biochemistry, Biology, Pharmaceutical Sciences, or related field.
• Minimum 3 years of Quality Control experience in a GMP‑regulated pharmaceutical or biotechnology environment.
• Hands‑on experience with analytical instrumentation such as HPLC, UPLC, GC, FTIR, UV‑Vis, and dissolution systems.
• Strong understanding of GMP, GDP, USP, FDA, and ICH guidelines.
• Experience investigating OOS, OOT, and laboratory deviations.
• Excellent documentation, analytical, and problem‑solving skills.

• Experience with LIMS, Empower, Lab Ware, or similar laboratory systems.
• Knowledge of stability programs and method validation.
• Experience supporting regulatory inspections and audits.