Continuous Improvement Specialist- Manufacturing Operations
Newark Metro Area, NJ
1. Purpose and Scope of Position:
The Specialist, Continuous Improvement, is responsible for supporting continuous improvement efforts related to *****cell and gene therapy processing***** activities within the GMP Manufacturing suite. The Specialist will work collaboratively with the manufacturing, development and quality teams to gain knowledge of cell culture processes and compliance requirements and *****actively participate in major deviations/investigations and CAPA s in regard to Clinical Manufacturing*****. In addition, the Specialist will assist in developing and maintaining various programs and systems to ensure compliance and quality. This may include but not be limited to training, quality system organization and continuous improvement endeavors.
2. Duties and Responsibilities:
Under the direction of the Continuous Improvement Team, the Specialist will work cross-functionally to perform the following:
Initiate deviations and perform routine investigations.
Participate in cross functional investigative teams deploying specific investigative principals
as necessary to ensure root cause analysis and corrective action(s).
Ensures corrective actions and improvements are shared and incorporated into the
Generate and execute CAPA documents to support response to deviations, audit findings and
independent corrective actions.
Collaborate with QC team to prioritize and lead Continuous Improvement initiatives
Train team for CAPA related findings.
Basic understanding of site quality systems, with the ability to push documents through change control for the team.
Interact and collaborate with departments (on and offsite) as well as vendors, consultants,
and other external services providers.
Basic proficiency in MS Word, Outlook, Excel, PowerPoint, Project and Visio
Basic critical thinking and decision-making skills
Basic time management, organizational, and multi-tasking abilities
Ability to solve routine complex problems
Basic technical writing and verbal communication skills
CRITICAL ****Basic knowledge of cGMPs****
Ability to work independently without direct supervision and work within cross-functional teams
Basic knowledge of flow cytometry and microbiology techniques
CRITICAL *****cell and gene therapy processing*****
CRITICAL *****actively participate in major deviations/investigations and CAPA s in regard to Clinical Manufacturing****
B.S. in a scientific or engineering discipline
2 or more years relevant experience, preferably in a GMP or regulated environment