Quality Control Analyst

Job Title: QC Analyst – Deviation Management

Location: New York (Onsite)

Duration: Long-Term Contract

Position Overview

We are seeking a detail-oriented QC Analyst with strong experience in deviation writing and investigation within a pharmaceutical manufacturing environment. The ideal candidate will have hands-on Quality Control laboratory experience along with a solid understanding of GMP compliance, root cause investigations, and regulatory documentation practices. This role will play a critical part in ensuring product quality, regulatory compliance, and continuous improvement initiatives.

Key Responsibilities

• Lead and author laboratory investigations and deviations (OOS, OOT, OOE, atypical results) in compliance with cGMP guidelines.
• Perform thorough root cause analysis using tools such as Fishbone, 5 Whys, and risk assessment methodologies.
• Collaborate with cross-functional teams including QA, Manufacturing, and Validation to drive timely closure of deviations.
• Ensure accurate and detailed documentation of investigations in quality systems (TrackWise, Veeva, or similar QMS platforms).
• Review analytical data generated from testing (HPLC, GC, UV, dissolution, wet chemistry, etc.) to support investigations.
• Support CAPA initiation, implementation, and effectiveness checks.
• Assist in internal and external audits by providing investigation documentation and technical justifications.
• Ensure compliance with FDA, ICH, and company SOP requirements.
• Identify trends in laboratory deviations and recommend process improvements.

Required Qualifications

• Bachelor’s degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or related scientific discipline.
• 3–7+ years of QC experience in a pharmaceutical manufacturing environment.
• Strong hands-on experience in deviation writing and investigation management.
• Experience handling OOS/OOT investigations in accordance with FDA guidance.
• Knowledge of cGMP, FDA regulations, ICH guidelines, and data integrity principles.
• Experience using QMS systems such as TrackWise, Veeva, MasterControl, or similar.
• Excellent technical writing and documentation skills.
• Strong analytical thinking and problem-solving abilities.

Preferred Qualifications

• Experience supporting regulatory inspections.
• Knowledge of stability programs and trending analysis.
• Prior experience in solid oral dosage, sterile, or biologics manufacturing environments.

Key Skills

Deviation Writing | OOS/OOT Investigations | Root Cause Analysis | CAPA | cGMP Compliance | QMS (TrackWise/Veeva) | Analytical Testing | FDA Regulations | Data Integrity | Audit Support.