Quality Control Chemist Phillipsburg, NJ $36-$40/hr The Quality Engineer will lead and support site quality assurance programs, regulatory compliance initiatives, and continuous improvement activities. This role is responsible for supporting quality systems including CAPA, cGMP, complaint investigation and response, ISO systems, stability, SPC, and validation. The ideal candidate has strong quality engineering experience in pharmaceutical, biotechnology, and/or chemical environments and is comfortable working directly with customers, vendors, regulatory bodies, and cross-functional teams to resolve quality issues and maintain compliance.

Quality Engineer Responsibilities:

Implement tactical and operational quality assurance goals focused on compliance with quality standards and continuous improvement initiatives. Support new testing protocols, inspection processes, regulatory compliance measures, and operational quality assurance plans. Manage quality assurance projects and processes, including supplier audits, process validation initiatives, and product quality improvement activities. Investigate and resolve quality issues by evaluating multiple factors, balancing production efficiency with defect reduction, and troubleshooting testing or process inconsistencies. Develop and implement solutions using root cause analysis, defect prevention strategies, and updates to standard operating procedures. Serve as a key customer contact for complaint investigations, inquiries, audits, and quality-related communications. Host and manage customer audits, certification/surveillance audits, and internal audit program activities. Collaborate with cross-functional departments to integrate and maintain quality systems and ensure regulatory requirements are met.

Quality Engineer Qualifications:

Minimum of five years of experience in quality engineering or a related role is required. Experience working within pharmaceutical, biotechnology, and/or chemical environments is required. Experience working within cGMP and

ISO 9000

regulated environments is required. Knowledge of cGMPs, ICH

Q7, IPEC

guidelines, ISO regulations, and FDA requirements is required. Experience supporting CAPA, complaint investigation, ISO systems, stability, SPC, and/or validation is strongly preferred. Bachelor's degree in chemistry or a related field is required. Strong communication skills with the ability to work with customers, vendors, regulatory bodies, and internal teams are required. Must be able to work onsite in Phillipsburg, NJ, Monday through Friday, 8:00 AM to 5:00 PM. #INDHS