Quality Control Chemist Lead

Quality Control Chemist LeadHatfield, PA Position may support two sites and candidates must be able to travel to our sites as neededCOMPANY SUMMARYAt Biolyst Scientific, we understand the evolving needs of clinicians and scientists in a world of supply chain disruptions and the demand for scientific advancements. We offer more than just order fulfillment, we provide partnership, expertise, and a genuine investment in your success. Our team blends industry knowledge with passion to deliver innovative solutions that drive medical and scientific progress. We are big enough to deliver, small enough to care.POSITION SUMMARYThe Quality Control Chemist Lead oversees the quality control (QC) processes at Biolyst Scientific, ensuring that products meet all regulatory standards and internal quality benchmarks. This role involves managing QC operations and implementing robust quality systems to ensure the highest standards of product integrity and compliance.ESSENTIAL JOB FUNCTIONSQuality Control Oversight:Perform chemical and physical testing of raw materials, in-process materials, and finished products in accordance with established procedures and specifications.Operate and maintain laboratory equipment, including HPLC, gas chromatography, sonicator, UV-Vis, viscosity meter, centrifugator, refactometer, microscopy, pH meter, titration pole, spectrophotometers, and other analytical instruments.Manage Stability Program, including resources, tests, trends and reports.Ensure all testing is performed accurately and documented in compliance with GMP, GLP, GDP and FDA regulations.Regulatory Compliance:Support during audits and inspections by regulatory agencies.Stay current with industry regulations and best practices and ensure that all QC processes adhere to these standards.Method Development and Validation:Develop, validate, and optimize analytical methods for product testing.Troubleshoot and resolve issues related to analytical methods and equipment.Collaborate with research and development teams to support product development and improve existing methods.Data Analysis and Reporting:Analyze and interpret QC data to identify trends, potential issues, and areas for improvement.Prepare and present detailed reports on QC activities, test results, and performance metrics to senior management.Implement corrective and preventive actions (CAPAs) based on data analysis and feedback.Continuous Improvement:Drive continuous improvement initiatives within the QC department to enhance efficiency, accuracy, and product quality.Participate in cross-functional teams to address quality issues and implement solutions.Inventory and Resource Management:Manage the inventory of QC supplies and reagents, ensuring availability and proper storage.Oversee the maintenance and calibration of QC instruments and equipment.Prepare and review laboratory documentation, including test methods, protocols, reports, and standard operating procedures (SOPs).SKILLS AND ABILITIESStrong knowledge of QC methodologies, USP requirements, FDA regulatory requirements, and industry best practices.Proven team and leadership management skills.Excellent analytical, problem-solving, and organizational abilities.Proficiency in analytical instruments and techniques (e.g., HPLC, GC, spectroscopy).Effective communication and interpersonal skills.MINIMUM REQUIREMENTSEducation: Bachelor's or Master's degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field.Experience: Minimum of 5-7 years of experience in quality control or regulatory within the life sciences or diagnostics industry.Relevant certifications (e.g., ASQ Certified Quality Auditor) are a plus.Biolyst Scientific provides equal employment opportunities to all persons and prohibits employment decisions based on race, religion, color, creed, national origin, sex, age, disability, political affiliation, protected veteran status, or sexual orientation.

Created: 2024-11-07