Quality Control Chemist – Pharmaceutical Manufacturing

Quality Control Chemist – Pharmaceutical Manufacturing
Employment Type: Direct Hire
Shift: 1st Shift | 7:00 AM – 3:00 PM
Schedule: Monday – Friday | Potential Overtime and Saturdays
Experience Required: 6–8+ Years of Pharmaceutical Quality Control Experience
Industry: Pharmaceutical Manufacturing

Position Overview

We are seeking an experienced Quality Control Chemist to perform laboratory testing, analyze product quality, and ensure compliance with FDA regulations and pharmaceutical manufacturing standards.

The ideal candidate will have 6–8+ years of direct pharmaceutical quality control experience, strong knowledge of cGMP and FDA regulations, and hands-on experience with laboratory testing equipment, quality investigations, and corrective and preventive actions (CAPA).

This position requires strong analytical skills, attention to detail, and the ability to work collaboratively with Production and Quality Assurance teams in a regulated pharmaceutical environment.

Key Responsibilities

• Perform routine quality control testing of pharmaceutical products, raw materials, in-process materials, and finished products to ensure compliance with established quality standards.
• Operate, maintain, and calibrate laboratory testing instruments and equipment.
• Accurately document analytical test results, observations, non-conformances, and quality findings.
• Investigate product defects, testing inconsistencies, out-of-specification results, and manufacturing deviations.
• Prepare detailed investigation reports and recommend appropriate corrective and preventive actions (CAPA).
• Ensure compliance with FDA regulations, cGMP, cGxP, ISO standards, and established laboratory procedures.
• 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 accurate laboratory records, testing documentation, and quality control reports.
• Ensure proper calibration, preventive maintenance, and troubleshooting of laboratory instruments.
• Follow established Standard Operating Procedures (SOPs) and laboratory safety protocols.
• Support ongoing quality improvement efforts to maintain product consistency, safety, and regulatory compliance.

Required Qualifications

• 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 required.
• 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.
• Demonstrated experience investigating quality deviations, documenting findings, and preparing investigation reports.
• Knowledge of corrective and preventive action (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.

Preferred Qualifications

• 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.

Benefits

• Medical Insurance
• Dental Insurance
• Vision Insurance
• 401(k)

Important Experience Requirement

Direct pharmaceutical quality control experience is required. Candidates must have a strong background in pharmaceutical laboratory testing, regulatory compliance, laboratory instrumentation, and quality investigations. General quality control experience outside the pharmaceutical industry alone does not meet the requirements for this position.