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Associate Scientist

4 weeks ago

Summit, United States Crox RPO Full time

Job Title- Associate Scientist

Location- Summit, NJ

Direct Client



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 upon

change 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.