QA Chemist — Investigations & CAPA Leader

Atrium Staffing; Pearl River (NY); On-site; USD 48,000 - 62,000; Full time

Benefits offered by this job

Atrium Care Package available

Job summary

Atrium Staffing client, a GMP manufacturer, is seeking a QA Chemist with strong analytical chemistry expertise to lead and support investigations (OOS, OOT, and lab events) in QC labs. The role focuses on root cause analysis, CAPA, and ensuring compliance with cGMP and GLP standards.

You will collaborate with manufacturing and quality teams, generate metrics, maintain records, and participate in audits. Bachelor's in Chemistry or related field required; Master's preferred; immediate availability

Qualifications

• Hands-on analytical chemistry laboratory experience in pharma/biotech/medical device or biologics.
• Demonstrated experience conducting investigations and root cause analysis.
• Working knowledge of cGMP or GLP.
• Strong technical writing, analytical, and problem-solving skills.

Responsibilities

• Lead and support investigations for OOS, OOT, laboratory events, and process failures within QC labs.
• Apply analytical chemistry knowledge to guide root cause analysis and ensure investigation integrity and compliance.
• Partner with manufacturing, quality control, and other departments to complete thorough, compliant investigations.
• Track and drive timely closure of laboratory investigations.
• Identify, implement, and follow up on corrective and preventive actions (CAPA).
• Support generation of Quality Metrics, KPIs, and trending data.
• Maintain accurate spreadsheets/databases for investigation meetings and reporting.
• Participate in internal, customer, and regulatory audits/inspections.
• Prepare and deliver status reports and Quality Review Committee materials.
• Identify opportunities for continuous improvement in lab processes.

Skills

Analytical chemistry

Investigations/root cause analysis

cGMP/GLP knowledge

Technical writing

Problem solving

Education

Bachelor's degree in Chemistry or Biology

Master's degree in Chemistry or related field

Job description

Atrium Staffing client, a GMP manufacturer, is seeking a QA Chemist with strong analytical chemistry expertise to lead and support investigations (OOS, OOT, and lab events) in QC labs. The role focuses on root cause analysis, CAPA, and ensuring compliance with cGMP and GLP standards.

You will collaborate with manufacturing and quality teams, generate metrics, maintain records, and participate in audits. Bachelor's in Chemistry or related field required; Master's preferred; immediate availability