What are the responsibilities and job description for the Quality Specialist position at Eagle?
What We're Looking For
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).
What You Will Do
• 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 departments
Who You Are
• 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
Who We Are
Serving customers since 2004, Eagle offers the highest quality in preparation testing for sterility, bacterial endotoxins, microbial detection, beyond-use dating (BUD) determination and active ingredient potency. State-of-the-art equipment, combined with the experience and knowledge of our team, makes Eagle the best choice for all testing needs. The Eagle team is committed not only to performing the best quality control testing, but also working relentlessly with our customers on solutions if tests receive unexpected results. Learn more at www.eagleanalytical.com.
