The Quality Specialist is responsible for the review of analytical documentation including methods, validations, protocols, analytical data, reports (microbiology and chemistry logs and worksheets), investigations (OOS, NCR, CAR, DV, and customer complaints), and change control documentation. Possess the ability to interpret and apply Current Good Manufacturing Practices (cGMP), ISO 17025 standards, American Association for Laboratory Accreditation (A2LA) requirements, U.S. Pharmacopeial Convention (USP), and Good Laboratory Practices (GLP).
Essential Responsibilities• Ensure compliance with Eagle policies and Standard Operating Procedures (SOPs) and Quality Management System.• Ensures ISO 17025, cGMPs, cGLPs, USP guidelines are interpreted and followed throughout the Eagle.• Write, review, and approve SOPs, test methods, laboratory reports, laboratory logs/worksheets, work instructions, forms, deviations, CAPA’s, change controls, and other relevant GMP records for compliance.• Review laboratory test reports, environmental monitoring, and quality control data.• Support and conduct internal audits of quality documentation and system and perform daily walk-through audits to ensure compliance of all departments.• Review root cause analysis and implementation of corrective action for process related concerns.• Assist in creating and maintaining company quality documentation, such as quality manuals, quality procedures, etc.• Manage auditing and storage of quality documentation and quarantined items.• Responsible for the preparation of training materials for all departmentsQualifications• Minimum Bachelor of Science in life science or related field required.• Two (2) years’ experience in Quality Assurance, Sterile Compounding and/or GMP production facility preferred.• Two (2) years’ experience with FDA regulated operations (cGMP processes) preferred.• Strong Microsoft Office with ability to input data into other software programs.• Excellent organizational, interpersonal, and time management skills.• Excellent attention to detail with strong verbal and written communication skills.• Ability to provide conflict resolution, i.e., quality issues operations.• Ability to work in a collaborative team environment.• Knowledge of 21 CFR Part 210 & 211 a plus.Certifications:• ASQ preferred
