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Senior QC Engineer

SUMMIT, NJ

Posted: 01/25/2023 Job Number: 22947926

Job Description

SENIOR QC ENGINEER
SUMMIT, NJ
100% Onsite.

Project Description:
  • The Senior Scientist is responsible for supporting compliance related activities within the S12 Quality Control department in direct support of clinical and commercial CAR T manufacturing operations.
  • This includes the ability to interface with cross functional groups, independently perform tasks, interpret results, author protocols/reports, conduct thorough root cause investigations (including experiment design and hypothesis testing), identify robust corrective and preventive actions (CAPA) and troubleshoot complex problems.
  • Additionally, the Senior Scientist will be responsible for continuous improvements, and ownership of change management records within the QC department.
  • Conduct thorough investigations (OOS, OOT, Environmental Monitoring, deviations, etc.) utilizing root cause analysis tools.
  • Perform GEMBA walks with stakeholders to better understand process steps, and evaluate the need to make process improvements, with the coordination of Subject Matter Experts.
  • Identify 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.
  • Initiate change control documentation and assist other QC functional groups with change management documentation.
  • Identify functional area SMEs to perform impact assessments as part of the change management process.
  • Ensure all investigations, CAPAs and change controls 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 QC during audits and site inspections for QC compliance related inquiries.
  • Handle complex issues and solve problems with minimal guidance.
  • Provide mentorship, guidance, and training to junior 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 QC, living the " patients first mission and fostering a " Right First Time mindset.
Required Skills:
  • Requires a Bachelor's Degree in science, preferably in Biochemistry, Immunology, Molecular and Cellular Biology, Biology, Microbiology or related discipline (advanced degree preferred).
  • Minimum Bachelor's degree required, Master's degree preferred in science or engineering, preferably in Biochemistry, life sciences or related engineering discipline .
  • 5+ years of relevant work experience, preferably in a health authority regulated environment.
  • An equivalent combination of education and experience may substitute.
  • Advanced working experience of deviation investigations utilizing root cause analysis tools.
  • Working experience in the CAPA process and ability to identify and verify effectiveness.
  • Working experience in the change management and associated change control processes.
  • Advanced 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.
  • E xperience supporting health authority inspections.
  • Knowledge of data trending and tracking, including use of statistical analysis software.
  • 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 various analytical techniques such as ELISA, qPCR, Cell Concentration, Sterility, Mycoplasma, Endotoxin, flow cytometry, and Environmental Monitoring.
  • Hands on experience preferred with Manufacturing Environmental Monitoring programs, which includes viable and non-viable air particulates, surface sampling and personnel monitoring.
  • Knowledge of Manufacturing class designation, such as Class D, Class C and Class A.
  • Strong understanding of Contamination Control, such as air flow, movement of materials and personnel.
  • Ability to mentor junior associates to foster and develop their expertise.
  • Previous experience in a gene or cell therapy facility is preferred (CAR-T a plus).

WORKING CONDITIONS (US Only):
  • The incumbent will be working 80% to 90% of the time in an office environment.
  • The incumbent will be working 10% to 20% of the time in a manufacturing and/or laboratory setting.
  • The incumbent may travel between NJ sites for training, meetings, or corporate events on occasion.
  • The incumbent will need to have flexibility to work extended hours (> 8 hours/day), weekend and/or holidays when required to meet deadlines.

This 6+ month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Rose: Rose@alphaconsulting.Com

ALPHA'S REQUIREMENT #23-00209
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE

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Rose Minchello

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