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Quality Assurance Inspector III

Andover, MARandstad LifeSciences


Chat with me now! - https://flashrecruit.com/jobs/296060
 

Job Title: Quality Assurance Inspector III


Job Summary

  • The individual will provide Quality Assurance oversight in support of a site MCS upgrade project. 

Job Responsibilities

  • 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.

Education & Qualifications

  • Bachelor’s Degree in engineering or life sciences
  • 5 years of validation/QA experience in a GMP environment (preferably with automation/software experience)
  • Experience with change control as a Quality Assurance approver
  • 1 year of experience with SAP/Trackwise change control software (or similar)
  • Experience working with DeltaV controlled systems is preferred
  • Proficient in reviewing executed validation documents (automation OQ, deviations, change managements, specifications, summary reports, etc.)
  • Knowledge of cGMP regulations as they pertain to the pharmaceutical/biopharmaceutical industry.
  • Thorough understanding of software automation OQ validation testing (DeltaV experience preferred)
  • Experience with GAMP
  • Identify and address any potential quality impact throughout the project
  • Understanding of the validation life cycle

Benefits

  • Medical, Dental, and Vision Insurance
  • 401K Plan with Company Match
  • Life and AD&D Insurance

 


Chat with me now! - https://flashrecruit.com/jobs/296060