QA & Validation Intern

Job Title

QA & Validation Intern

Requisition

JR000015689 QA & Validation Intern (Open)

Location

Port Allen, LA

Additional Locations

Job Description Summary

Job Description

The QA and Validation Projects Intern will learn the regulations, standards, and guidance that support both pharmaceutical and medical devices manufacturing and quality systems. This individual will support the Quality at the Port Allen, LA manufacturing facility in a wide range of functions including Management of Change (MOC) action items execution support, technical writing, compiling data, and creating dashboards for trending. In addition, in this role the individual has a unique opportunity to work on continuous improvement projects to support the Port Allen, LA manufacturing facility’s transformation initiatives through Kaizen initiatives. This includes learning lean manufacturing principles for improvement.

Key Responsibilities:

• Quality Systems (QS) Project Coordination including tracking status of open projects and actions, calling meetings, and assistance with completion of open actions.

• Automate/ Optimize Quality System Reports for improved tracking

• Record retention optimization project, includes assisting with indexing GMP documents for preparing for offsite storage, scanning GMP documents for retention in the eDMS and organization of the document control room.

• Create a trending dashboard for Notice of Events for timely trend identification.

• Assist with streamlining hold process updates.

Minimum Requirements:

Education and Experience:

• Must be currently enrolled in an undergraduate or graduate program.

• Experience in self-leading a project

• Experience in working in a team environment.

• Knowledgeable in Microsoft applications (Word, PowerPoint, Excel, Outlook)

Skills/Other Qualifications:

• Time management

• Technical writing

• Computer applications

• Organizational Skills

• Presentation Skills

Relationship with Others/Scope of Position:

The QA and Validation Projects Intern will work with various functions at the Port Allen, LA manufacturing facility including Site Quality, Quality Control, and Manufacturing Operations, The Project Coordinator can also work with other members of the global Quality organization.

Working Conditions: onsite role; 5 days/week onsite

Disclaimer:  The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications.  Management reserves the right to change or modify such duties as required.

#LI-GN1

At Keenova, we believe that no one should be alone in their pursuit of better health. This purpose drives us as we pair quality therapeutics with human support—showing up in big moments and small to help patients find comfort and confidence.

 

We bring deep expertise and resolve to every therapeutic area we serve, including immunology, urology, men’s health, orthopedics, critical care, and pediatric endocrinology. We work with patients, care partners, and physicians to help them navigate healthcare system complexity and access therapies that make a meaningful difference.

 

We are Keenova—keen to solve, keen to serve. Learn more at www.keenova.com.