Job opening
QA Chemist - 407011
Filed under Staffing and Recruiting
Full 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
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.
- 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.
- Related industry certifications in Quality.
- Experience presenting to regulatory or customer auditors.
- Prior participation in continuous improvement initiatives.
- Availability to start immediately.
- 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.
- Atrium Care Package available, upon eligibility (including healthcare plans, discount programs, and paid time off).