Quality Systems Specialist - Sterile Drug Product Manufacturing

Quality Systems Specialist - Sterile Drug Product Manufacturing

Johnson Service Group, is looking to hire a Quality Systems Specialist for a biotech manufacturing company in Carlsbad, CA. Direct hire | Onsite | Pay range for this position is $36 - $40 per hour Position Overview We are seeking an experienced Quality Systems Specialist to lead investigations, root-cause analyses, and CAPAs within a sterile drug product manufacturing environment. This role will ensure compliance with FDA, cGMP, ISO, and ICH requirements while maintaining inspection readiness.

Key Responsibilities Lead thorough investigations into batch deviations, nonconformances, out-of-specification results, and product failures Investigate customer complaints by reviewing production records, historical quality data, and interviewing appropriate personnel Perform root-cause and risk analyses and develop appropriate CAPAs Ensure investigations and manufacturing documentation comply with FDA, cGMP, ISO, ICH, and other applicable requirements Conduct historical quality-system searches to identify similar events, recurring issues, and potential trends Prepare and present quality metrics, investigation findings, and reports to support management decision-making Partner with Manufacturing and other departments to ensure investigations are accurate, complete, and resolved on time Monitor CAPA effectiveness and drive assigned actions through completion Lead quality-related training sessions as needed Identify and support process improvements related to investigations and quality systems Lead the internal audit program Assist with hosting client, supplier, and regulatory audits and coordinate responses to audit findings Support visual inspection activities for finished products Perform other related duties as assigned Qualifications Bachelor's degree in biology, chemistry, engineering, life sciences, or a related field strongly preferred Minimum of four years of experience in pharmaceutical or biotechnology manufacturing Significant experience working in a GMP-regulated environment and conducting quality investigations Strong knowledge of FDA regulations, cGMP requirements, and ICH guidelines Demonstrated experience with root-cause analysis, risk assessment, deviations, CAPAs, and nonconformances Excellent technical writing, analytical, and problem-solving skills Strong attention to detail with the ability to manage multiple priorities in a deadline-driven environment Ability to make sound decisions regarding product and material quality Excellent communication skills and the ability to collaborate across departments Strong initiative, accountability, and willingness to take ownership of projects through completion Experience with Master Control and Net Suite is a plus