Catalent Cell and Gene Therapy is looking to recruit a QA Associate III - Analytical to join our growing team in Harmans, MD.
QA Associate III - Analytical is responsible to provide QA support to the Analytical Development and Quality Control Units of a Contract Research/Manufacturing Organization, performing analytical method development and review of data generated as part of in-process and release testing biopharmaceuticals.
The QA Associate III - Analytical role is critical to our patients. The QA Associate III - Analytical has the main responsibility to provide QA oversight and support to client projects making sure the process and document records are in compliance with patient safety in mind, executing with efficiency always. Quality, safety, and on-time delivery are a must to be successful in this role!
Maintain and administer quality systems including document management, investigation/deviations, CAPA tracking, risk management, quality metric tracking, training, and other quality systems
Interface and communicate with the Client, Analytical Development teams, Technology Transfer group, and the BMP Manufacturing departments in meeting project timelines, providing deliverables, and resolving issues
Perform quality review of Analytical Development documentation including raw data, test methods, protocols, and executed method qualification report.
Support external client audits
Perform periodic walkthrough audits of Analytical Development and Quality Control laboratories
Implement continuous improvement initiatives
Provide quality oversight of the process and analytical method development in an R&D setting for client projects
Provide quality oversight in compliance with GMPs for Quality Control testing of clinical product
Link to the job description and application - https://catalent.wd1.myworkdayjobs.com/External/job/Gaithersburg-MD/Quality-Assurance-Associate-III---Analytical_0052681-3
Minimum of a B.S. in a Life Sciences discipline
+6 years’ experience within the biologic, biopharmaceutical, or regulated pharmaceutical industry
+4 years experience in Quality Assurance/Quality Control function
Familiarity with Good Manufacturing Practices (GMPs), 21 CFR 210/211/600s, USP and ICH Guidelines
Have the knowledge, and ability to apply basic scientific and regulatory principles utilized to solve operational, as well as routine quality tasks
Exposure to Lean Operational Excellence highly desirable
About Catalent Pharma Solutions
Catalent hires people with a passion to make a difference to the health of millions of people globally. Your expertise, coupled with Catalent’s advanced technologies and collaboration with thousands of innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives. Interested in learning more about life at Catalent? https://www.catalent.com/about-us/overview/