Job Description
The primary objective of this role is to ensure that laboratories and associated equipment are qualified and maintained according to cGxP standards. This involves ensuring that all necessary documentation, including qualification documents and SOPs, are accurate and up-to-date.
This position requires a high level of organization and attention to detail, as well as strong communication skills. The ideal candidate will be able to work independently and as part of a team to achieve goals.
Responsibilities
* Project leadership for the initial qualification of laboratories, analytical instruments, and systems.
* Planning and execution of qualification activities to ensure readiness and release of instruments according to business needs.
* Ensuring the qualification/calibration status of analytical equipment and associated utilities and facilities.
* Change control: Initiating and owning change requests associated with laboratory implementation, as well as approving CAPA and task loop.
* Authoring and reviewing SOPs within the area of responsibility.
* Maintaining laboratories according to cGxP standards and ensuring compliance with applicable regulatory requirements and guidelines.
* Contributing to GxP audits/inspections and ensuring methods and procedures are up-to-date.
* Managing documentation and methods according to cGxP.
* Managing external service providers and instrument vendors for laboratory qualification processes.
Leadership & Culture
* SUPPORTING THE ORGANIZATION BY IDENTIFYING AND REVIEWING TRAINING FOR ASSOCIATES.
* ENSURING ASSOCIATES ARE QUALIFIED FOR A GMP TASK BEFORE INDEPENDENT PERFORMANCE.
* MONITORING TRAINING COMPLIANCE FOR ASSOCIATES.
* IDENTIFYING AND MAINTAINING A LIST OF SUBJECT MATTER EXPERTS FOR IN-SCOPE AREAS OF EXPERTISE.
* CREATING A WORK ENVIRONMENT THAT ENABLES HIGH EMPLOYEE ENGAGEMENT.
* ROLE MODELING THE CULTURE ASPIRATION OF BEING CURIOUS, INSPIRED, AND UNBOSSED.