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Associate Scientist
3 months ago
Knowledge, Skills, and Abilities:
Working experience in 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, and apply Global Regulatory
and cGMP requirements.
Ability to support health authority inspections.
Knowledge of data trending and tracking, including the 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) or Infinity.
Hands-on experience preferred with CAR-T or biopharmaceutical manufacturing and Quality
Control.
Education and Experience:
Requires a Bachelor's Degree in science or engineering, preferably
in Biochemistry, life sciences, or related engineering discipline (advanced
degree preferred).
Minimum 1 year 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.
DUTIES AND RESPONSIBILITIES:
Conduct thorough investigations (Environmental Monitoring, deviations, etc.) utilizing root
cause analysis tools.
Lead investigations and cross-functional investigation teams, and close reports on time
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 uponchange implementation and develop an app, appropriate mitigation strategy. May Initiate change control documentation
Identify functional area SMEs to perform impact assessments as part of the change
management process. Cross-functional
Ensure all investigations are completed promptly. Notify stakeholders of any
delays promptly.
Provide technical support for manufacturing investigations / CAPAs / change controls as
needed.
Support deviation investigation defense during authority-regulated audits and site inspection-related inquiries.
Handle complex issues and solve problems with minimal guidance.
Serve as author or technical reviewer of departmental procedures as appropriate.
Employ lean manufacturing / Six Sigma principles to continuously improve products, processes and
systems.
Continuously support S12, living the patient's first mission and fostering a Right First Time
mindset.
WORKING CONDITIONS (US Only):
The incumbent will be working 80% to 90% of the time in an office environment promptly
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.
Comments
100% onsite
Work Schedule: Wed-Sat- (4 pm- 2 am) EST
Bachelor's degree required
Duration: 6 months(possibility of extension for the right candidate depending on performanceinspection-related
