Job Description Job Description Analyst, Quality ControlPosition SummaryWe are seeking a detail-oriented Quality Control Analyst to support quality control testing, material inspections, documentation review, and product/material release activities. This position plays an important role in maintaining quality standards and ensuring compliance with GMP and applicable regulatory requirements.The ideal candidate will have a strong scientific background, experience working in a quality control or analytical laboratory environment, excellent attention to detail, and the ability to effectively communicate and collaborate with internal teams, suppliers, and vendors.Key ResponsibilitiesConduct visual inspections of purchased raw materials, components, and other materials.Review supplier Certificates of Analysis (CoAs) for accuracy and compliance with established requirements.Review and approve assays, test results, and material release documentation.Work with applicable USP and EP monographs to support testing and quality requirements.Perform aseptic sampling of raw materials and components in accordance with established procedures.Review, revise, and maintain SOPs, test methods, raw material specifications (RMSs), forms, and other quality documentation.Collaborate with suppliers and vendors to resolve quality-related questions and issues.Maintain accurate and complete documentation in accordance with GMP and company procedures.Support material release activities and ensure quality requirements are met.Train and provide guidance to junior analysts as needed.Assist with investigations, process improvements, and other quality control activities as assigned.Perform other duties and responsibilities as required.Minimum QualificationsBachelor's degree in Chemistry, Biology, or a related scientific field, or equivalent relevant experience.2+ years of Quality Control or analytical laboratory experience.Working knowledge of GMP and quality control principles.Experience with analytical laboratory techniques, testing, and quality documentation.Familiarity with USP and EP monographs preferred.Experience with aseptic sampling preferred.Strong attention to detail and ability to accurately review technical documentation.Strong written and verbal communication skills.Ability to work independently while also collaborating effectively with cross-functional teams.Ability to prioritize multiple tasks and meet deadlines in a fast-paced environment.Preferred QualificationsExperience in a pharmaceutical, biotechnology, or other regulated laboratory environment.Experience reviewing Certificates of Analysis and material release documentation.Experience with SOPs, test methods, specifications, and controlled documents.Previous experience training or mentoring junior laboratory personnel.
Not specified in the original listing.
Not specified in the original listing.
