An industry leading specialty pharmaceutical company, specifically focused on combination product manufacturing, is actively looking for two QA Specialists to join their team in Lexington!
Ideally, one will have strong HPLC experience, mostly found in QC candidates, while the other will have a QA background, specifically with pharmaceutical/manufacturing experience.
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
The company is very active in this search, do not miss out on your chance to work for this awesome company. Apply TODAY!