Previous Job
Previous
Quality Assurance Inspector III
Ref No.: 17-07257
Location: Andover, Massachusetts
Start Date / End Date: 01/08/2018 to 01/07/2019
Job Description: Job Title: Quality Assurance Validation Specialist
Job Class: IT Technical

• The individual will provide Quality Assurance oversight in support of a site MCS upgrade project. The individual will be responsible for the quality review and approval of validation documentation such as protocols, deviations, change managements, and change controls. The documentation will primarily be automation OQ testing based on DeltaV software, therefore; experience in an automated 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 protocols, deviations, and change managements.
• Ensure compliance to governing SOPs, validation plans, and protocols throughout the project.
• Release equipment back to GMP manufacturing as part of change control.
• Have the ability to 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 personnel, as applicable.
Position Comments visible to MSP and Supplier: • Position will be office/desk based. Position is first-shift with potential for second shift coverage, on occasion. No travel from the site is required.

• Interactions will primarily be between engineering/validation personnel. Some interaction will also occur with operation personnel, as applicable.