Roles and Responsibilities:

• The individual will provide Quality Assurance oversight in support of a site product enabling engineering project.


• The individual will be responsible for the quality review and approval of validation and change control documentation such as protocols, test plans, various validation testing documents, deviations, and change controls.


• The documentation will span the breadth of validation and change control requirements for biopharmaceutical processing and Quality Control (QC) instruments and therefore validation and quality assurance experience in a manufacturing and / or Quality Control laboratory GMP environment is required.


• The individual will also ensure that the execution of documents adheres to the governing SOPs, protocols, project plans, cGMP, etc.


• Upon completion of their review, the individual will also be responsible for the release of equipment back to GMP manufacturing.


• Provide QA review of executed validation documents such as change controls, protocols and test plans, validation testing documents, and deviations.


• Ensure compliance to governing SOPs, validation plans, and protocols throughout the project.
  
  Release equipment and / or instruments for GMP manufacturing and / or Quality Control use as part of change control.


• Can independently assess impact and re-testing requirements in the event of a deviation.


• Interactions will primarily be between Engineering/Validation personnel. Some interaction will also occur with operation and / or quality control lab personnel and, as applicable


• Proficient in reviewing executed validation documents (change controls, protocols and test plans, validation testing documents, deviations, etc.)


• Knowledge of cGMP regulations as they pertain to the pharmaceutical/biopharmaceutical industry.


• Thorough understanding of the equipment and / or instrument validation life cycle, including change control.


• Identify and address any potential quality impact throughout the project


• Position will be office/desk based. Position is first shift with potential for second shift / weekend coverage, on occasion. No travel from the site is required.

Education and Experience:

• Equipment and instrument validation experience is required


• 8+ years of experience is preferred


• QC Micro and QC analytical lab instruments validation


• Manufacturing floor instrument and equipment validation


• Execution of test plans, protocol, and deviation review