Project Manager, Quality Technology Systems & Solutions

Position Summary:

The Quality Technology Systems and Solutions (QTSS) Project Manager is responsible for the following:

• Planning and management of projects internal to the Quality Department (including QC, QA and Validation)
• Serves as Point of Contact (PoC) for Quality departments on larger projects with heavy quality involvement
• Acts as a back up for Administration of Quality Control Software Systems, including but not limited to Empower, Tiamo, OMNIC, ECLIPSE, DataPro2, etc.
• Assists with Equipment Implementations and Change Management for existing Quality Equipment and Systems

This position is onsite and reports directly to the Sr. Manager, QTSS.

Principal Duties and Responsibilities include the following:

• • New software implementations where quality is the business or technical owner
  • Quality improvement projects across multiple departments
• Serves as a Point of Contact for Quality (QA, QC and Validations departments) on company wide projects including:
  • Laboratory build outs
  • Software implementations where Quality is not the business or technical owner
• Will support and oversee Equipment Implementation for QC systems including:
  • Change management
  • Authorship of Administration and Usage SOP’s
• Works with business owners to justify and procure new capital equipment or systems for the Quality departments
• Coordinates with external groups including calibrations, validation, facilities, IT, QA and equipment vendors to bring in and set up new equipment
• This role provides back up support to the system administrators and assists with maintenance of routine operation of the analytical instrument data systems, managing system access, ensuring high quality and timely system output, and all end user requests, including troubleshooting.
• Coordinates and supports GMP IT updates related to QC systems, as required
• Builds and maintains strong relationships and collaborates closely with other departments which interface with Quality Systems, including QC Raw Mats, QC Commercial, QC analytical, QC Stability and QC Micro, QA Compliance, QA Operations, QA Disposition, IT, Validations, Etc.

Qualification Requirements:

• Degree in a scientific field preferred.
• 5-10 to years of experience in an Analytical or QC Laboratory or with Equipment Implementation in a GMP setting
• Knowledge of Computer System Validation and 21 CFR Part 11 compliance requirements.
• Experience with analytical test equipment software validation and administration
• Knowledge of applicable USP, ICH, EP guidelines relating to QC Equipment
• Waters Empower experience, with laboratory experience desired
• Must have good communication and organizational skills.
• Must be organized

Working Conditions:

• Office and laboratory/clean room