Manufacturing and Quality Control Investigator

1 week ago

Akron, Ohio, United States MassGenics Full time
Job Summary

We are seeking a highly skilled Scientist/Engineer to join our team at MassGenics. As a key member of our organization, you will be responsible for leading manufacturing and quality control investigations, utilizing root cause analysis tools to identify and resolve complex problems.

Key Responsibilities
  • Conduct thorough investigations of out-of-specification (OOS), out-of-trend (OOT), and environmental monitoring events, as well as deviations and other quality control issues.
  • Lead cross-functional investigation teams and close reports in a timely manner, ensuring that all necessary corrective and preventive actions (CAPAs) are implemented.
  • Perform Gemba walks with stakeholders to better understand process steps and evaluate root cause analysis.
  • Work with functional teams to propose effective CAPAs, develop CAPA plans, and ensure CAPA effectiveness.
  • Assess potential impact and risk to product or process associated changes may have upon change implementation and develop an appropriate mitigation strategy.
  • May initiate change control documentation.
  • Identify functional area subject matter experts (SMEs) to perform impact assessments as part of the change management process.
  • Ensure all investigations are completed in a timely manner, notifying stakeholders of any delays.
  • Provide technical support for manufacturing investigations/CAPAs/change controls as needed.
  • Support deviation investigation defense during audits and site inspections for quality control compliance-related inquiries.
  • Handle complex issues and solve problems with minimal guidance.
  • Provide training to new investigation team members.
  • Serve as author or technical reviewer of departmental procedures as appropriate.
  • Support manufacturing and quality control testing of CAR-T products as needed.
  • Employ lean manufacturing/Six Sigma principles to continuously improve products, processes, and systems.
Requirements
  • Requires a Bachelor's Degree in science or engineering, preferably in biochemistry, life sciences, or a related engineering discipline (advanced degree preferred).
  • Minimum 3 years of relevant work experience, preferably in a health authority-regulated environment.
  • Previous experience working in a biopharmaceutical manufacturing facility is preferred (CAR-T a plus).
  • An equivalent combination of education and experience may substitute.
Preferred Qualifications
  • Working experience of deviation investigations utilizing root cause analysis tools.
  • Working experience in the CAPA process and ability to identify and verify effectiveness.
  • Technical writing skills and ability to collaborate effectively in cross-functional teams.
  • Proven ability to accurately and completely understand, follow, interpret, apply global regulatory and cGMP requirements.
  • Ability to support health authority inspections.
  • Knowledge of data trending and tracking, including use of statistical analysis software (a plus).
  • Demonstrate advanced problem-solving ability/mentality, technical adeptness, and logical thinking.
  • Ability to set priorities, manage timelines, and effectively react/manage changing priorities.
  • Ability to work with management (global and site) and support corporate and departmental goals.
  • Ability to communicate honestly, transparently, and effectively with peers, department management, and cross-functional peers.
  • Ability to utilize electronic quality systems such as eQRMs (Enterprise Quality and Regulatory Management system).
  • Hands-on experience preferred with CAR-T or biopharmaceutical manufacturing and quality control.
  • Ability to train new team members on the investigation process.

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