Quality Control Chemist – Pharmaceutical Manufacturing

Linked Professional Services•Piscataway, NJ

14h

About The Position

The Quality Control Chemist performs laboratory testing and analyzes product quality to ensure pharmaceutical products meet established quality standards and comply with FDA regulations and pharmaceutical manufacturing requirements. The role calls for 6–8+ years of direct pharmaceutical quality control experience, knowledge of cGMP and FDA regulations, and hands-on experience with laboratory testing equipment, quality investigations, and corrective and preventive actions (CAPA). The chemist works in a regulated pharmaceutical manufacturing environment and collaborates with Production and Quality Assurance teams. The position is scheduled for the first shift, 7:00 AM–3:00 PM, Monday through Friday, with potential overtime and Saturdays.

Requirements

Bachelor's or Master's degree in Chemistry, Biology, Life Sciences, or a related scientific field.
Minimum 6–8 years of quality control or related experience within the pharmaceutical industry.
Direct hands-on experience performing pharmaceutical laboratory testing and quality control procedures.
Strong understanding of FDA regulations, cGMP, cGxP, and pharmaceutical quality standards.
Experience operating, maintaining, and calibrating Quality Control laboratory instruments.
Experience investigating quality deviations, documenting findings, and preparing investigation reports.
Knowledge of CAPA processes and root cause analysis.
Strong technical documentation skills and experience maintaining accurate laboratory records.
Ability to analyze testing results, identify inconsistencies, and recommend corrective actions.
Excellent attention to detail, analytical thinking, and problem-solving abilities.
Ability to collaborate effectively with Production, Quality Assurance, and other cross-functional teams.
Must be authorized to work in the United States indefinitely without restriction or sponsorship.

Nice To Haves

Experience working with liquid pharmaceutical formulations, including oral solutions and suspensions.
Previous experience conducting investigations involving pharmaceutical product defects, deviations, or non-conforming materials.
Experience supporting laboratory quality improvements and regulatory compliance initiatives.

Responsibilities

Perform routine quality control testing of pharmaceutical products, raw materials, in-process materials, and finished products.
Operate, maintain, calibrate, and troubleshoot laboratory testing instruments and equipment.
Document analytical test results, observations, non-conformances, and quality findings accurately.
Investigate product defects, testing inconsistencies, out-of-specification results, and manufacturing deviations.
Prepare investigation reports and recommend corrective and preventive actions (CAPA).
Ensure compliance with FDA regulations, cGMP, cGxP, ISO standards, laboratory procedures, and SOPs.
Collaborate with Production and Quality Assurance teams to identify quality concerns, resolve deviations, and improve manufacturing processes.
Participate in quality investigations, root cause analysis, and continuous improvement initiatives.
Maintain laboratory records, testing documentation, and quality control reports.
Follow laboratory safety protocols and support quality improvement efforts to maintain product consistency, safety, and regulatory compliance.