• Permanent
  • Anywhere




Country: United States

Location : Summit, New Jersey

Post: Wed, 31 May 2023 06:52:10 GMT

Expires: Wed, 28 Jun 2023 23:59:59 GMT

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—————————— Job Description ——————————

Job Description:

Pay Range $51hr – $54.50hr


Conduct thorough investigations (OOS, OOT, Environmental Monitoring, deviations, etc.) utilizing root cause analysis tools.

Lead investigations and cross functional investigation teams, and close reports in a timely manner.

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 assure 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 SMEs to perform impact assessments as part of the change management process.

Ensure all investigations are completed in a timely manner. Notify stakeholders of any delays in a timely manner.

Provide technical support for manufacturing investigations / CAPAs / change controls as needed.

Support deviation investigation defense during audits and site inspections for QC compliance related inquiries.

Handle complex issues and solve problems with minimal guidance.

Provide training to new investigations 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.

Continuously support S12, living the patients first mission and fostering a Right First Time mindset.

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

Education and Experience:

Requires a Bachelors Degree in science or engineering, preferably in Biochemistry, life sciences or 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.

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