QA Chemist

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

Client Overview:

Our client is a GMP manufacturer committed to quality and regulatory excellence. The well-established Quality team ensures every product meets rigorous cGMP, FDA, and industry standards through robust laboratory investigation and continuous improvement processes. Our client is currently looking to add a QA Chemist to their team.

Salary/Hourly Rate:

$35/hr - $45/hr

Position Overview:

For the QA Chemist role, our client is seeking an experienced Analytical Chemist with a strong background in quality investigations to lead and support Out of Specification (OOS), Out of Trend (OOT), and laboratory event investigations. The QA Chemist combines hands-on analytical chemistry expertise with investigative rigor, driving root cause analysis, corrective actions, and cross-functional collaboration to maintain compliance and quality standards.

Responsibilities of the QA Chemist:

• The QA Chemist will 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.
• The QA Chemist will 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.

Required Experience/Skills for the QA Chemist:

• 4+ years of hands-on experience in an analytical chemistry laboratory (bench chemist) within the pharmaceutical, medical device, or biologics industry.
• Demonstrated experience conducting investigations and root cause analysis.
• Working knowledge of cGMP or GLP.
• Strong technical writing, analytical, and problem-solving skills.

Preferred Experience/Skills for the QA Chemist:

• Related industry certifications in Quality.
• Experience presenting to regulatory or customer auditors.
• Prior participation in continuous improvement initiatives.
• Availability to start immediately.

Education Requirements:

• Bachelor's degree in Chemistry, Biology, or a related field is required.
• Master's degree in Chemistry or a related field is preferred but not required.

Benefits:

• Atrium Care Package available, upon eligibility (including healthcare plans, discount programs, and paid time off).

Job Wrapping ID: #LI-AJ3