Overview
Quality Control Analyst Jobs in Massachusetts, United States at United Pharma Technologies Inc
Title: Quality Control Analyst
Company: United Pharma Technologies Inc
Location: Massachusetts, United States
Role: Quality Control Analyst
Location: Boston, MA | Onsite
Position Summary
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.
Key Responsibilities
- 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.
Required Qualifications
- 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.
Preferred Qualifications
- Experience with LIMS, Empower, LabWare, or similar laboratory systems.
- Knowledge of stability programs and method validation.
- Experience supporting regulatory inspections and audits.
