A rapidly expanding combination product manufacturer is actively looking to add TWO QA Specialists to their team, located in their Lexington, KY site.
Responsible for providing quality involvement and oversight during all stages of pharmaceutical development, manufacturing and testing. Also responsible for review of controlled cGMP documentation including any OOS that may have occurred during lot production. Participates during the release of raw materials, intermediates and final products. Audits documentation, records activities, and keeps management informed on quality issues.
- Supports the development and maintenance of Quality Systems as appropriate.
- Leads continuous improvement objectives to assure compliance with DEA and FDA regulations.
- Assists with the CAPA and Change Control Systems.
- Reviews, and approves cGMP documentation including procedures, validation protocols, development reports, specifications and other related documents.
- Develops and maintains metrics and trending reports for Compliance-related activities.
- Bachelor degree in a scientific discipline
- At least 2 years cGMP experience
- Knowledge of HPLC principles and ability to review data for accuracy and completeness
- Ability to assess problems, to identify solutions, to plan and implement necessary changes
- Experience in quality systems auditing (internal and/or external) preferred
- Knowledge of cGMP regulations and validation principles
Do not miss out on this opportunity! Apply TODAY!