JOB SUMMARY:

The primary focus of this position is the management and maintenance of the Total Particle Action Level (TPAL) Program. Other tasks may include review of investigations for quality related events triggered through the manufacturing process. Provide feedback to the investigation writer on the quality of the report with emphasis on compliance to SOP’s and cGMP. Must be the subject matter expert in the auditing/investigative process and provide the necessary leadership to assure continuous improvement in the mitigation of events associated with the manufacturing process. Independently lead Quality Engineering projects including identification of projects, definition of project scope, writing Change Controls, creating Engineering required documentation, and project tracking. Review and approve Quality documents such as SOPs, Change Controls, and QTO protocols, GTRs, Engineering Drawings, Maintenance Work Requests/Work orders, Inspector Qualification/Re-qualification, and challenge group creation and maintenance.

 

RESPONSIBILITIES:

Coordinate the Manual Inspection of Particle Rejects Identify / Characterize Particle Defects Calculate Particle Reject Rates and Individual Particle Type Reject Rates Manage Particle Library Provide guidance pertaining to the TPAL Program to the Inspection and Packaging Department as needed Review, revise and approve investigations in a timely manner to ensure compliance and timely product release and internal deadlines are met. Individual to provide direction for process improvements or preventative measures to avoid or minimize process deviations consistent with business requirements. Gather, assess, and distribute daily, weekly and monthly metrics. Perform QA Investigations or other assigned investigations as required. Revise and train individuals on the SOP's relating to the investigation process.  Participates in the development and delivery of training/refresher courses in quality systems and or GMP regulations and requirements and consultation as necessary. Identify and implement quality improvement projects. Lead projects to completion with minimal supervision. i.e., coordinate manual inspector training program and challenge group program. Review and approve Quality documents such as SOPs, Change Controls, and QTO protocols and GTRs

 

QUALIFICATIONS:

Must have excellent verbal and written communication skills, sound judgment and analytical skills to enable assessment of risk.  Resourceful, self-reliant, self-motivated and confident. Ability to work independently and be flexible to changing priorities. Strong personal computer skills.  Must have excellent teamwork and organizational skills. Must have Science /Engineering background and demonstrated ability to manage and complete projects.  

 

EDUCATION/EXPERIENCE:

Bachelor's degree in Science/Engineering with experience in an engineering or scientific (pharmaceutical manufacturing) discipline.  Five plus years experience in the areas of GMP regulations. Previous auditing experience is a plus.