Quality Control Specialist

Job Duties

• Perform routine and non-routine analytical testing, including techniques such as GC, HPLC, and wet chemistry, on raw materials, intermediates, and finished products
• Interpret analytical results to determine compliance with established specifications and investigate atypical or out-of-specification results
• Troubleshoot analytical methods, instrumentation, and laboratory processes as needed, and support method verification, transfer, and continuous improvement initiatives
• Lead or support quality investigations related to out-of-specification results, nonconforming materials, and customer complaints
• Conduct root cause analysis using structured problem-solving methodologies and develop appropriate corrective and preventive actions (CAPAs)
• Ensure investigations are thoroughly documented, completed in a timely manner, and aligned with company procedures and quality standards
• Execute and support Quality Management System (QMS) activities, including document control, change management, and deviation or nonconformance tracking
• Participate in internal audits and support audit readiness activities, ensuring compliance with internal procedures, regulatory requirements, and company quality policies
• Collaborate cross-functionally with production, R&D, procurement, and logistics teams to resolve quality issues and support product quality decisions, including material disposition
• Communicate analytical findings, investigation outcomes, and quality recommendations clearly and effectively to relevant stakeholders
• Support laboratory operations as needed, including management of laboratory inventory, procurement of supplies and reagents, and maintenance of an organized and compliant laboratory environment
• Provide guidance, training, and mentorship to QC Technicians and other laboratory personnel, as applicable
• Identify and implement opportunities for continuous improvement in laboratory operations, data integrity, and quality processes
• Participate in initiatives to enhance efficiency, standardize practices across sites, and strengthen overall quality system performance

Skills And Qualifications

• Strong working knowledge of analytical laboratory techniques: GC (gas chromatography); HPLC (high-performance liquid chromatography); wet chemistry
• Ability to accurately interpret analytical data and determine compliance with established specifications (GC; HPLC; other instruments)
• Demonstrated ability to troubleshoot analytical methods, instrumentation, and atypical results, along with a solid understanding of laboratory best practices, safety standards, and data integrity principles
• Proven capability to lead or support quality investigations, including out-of-specification results, nonconforming materials, and customer complaints, using structured problem-solving approaches such as root cause analysis
• Ability to develop, implement, and document corrective and preventive actions (CAPAs), assess risk, and make sound, data-driven quality decisions
• Working knowledge of Quality Management Systems (QMS), including document control, change management, and deviation or nonconformance processes, along with experience supporting or participating in internal or external audits
• Familiarity with regulatory and compliance expectations within a manufacturing or laboratory environment
• Ability to collaborate effectively with cross-functional teams, including production, R&D, procurement, and logistics, and to communicate technical information, investigation outcomes, and quality recommendations clearly and effectively
• Strong organizational skills with the ability to manage multiple priorities, maintain attention to detail, and meet deadlines in a dynamic environment
• Experience supporting laboratory operations such as inventory management, procurement of supplies, and maintenance of an organized and compliant laboratory workspace
• Demonstrated ability to provide guidance, training, or mentorship to QC Technicians, chemists, and other laboratory personnel, with a strong sense of ownership and accountability for quality outcomes and continuous improvement