Quality Investigation Scientist – CAR T (Onsite – Summit, NJ)

We are seeking a Quality Investigation Scientist – CAR T for our global pharmaceutical client. You will be responsible for leading manufacturing and QC investigation reports in support of S12 CAR T operations. This includes execution of thorough root cause investigations, interviewing personnel, hypothesis testing and interpretation of results, authoring investigation reports, identifying corrective and preventive actions (CAPA), and troubleshooting complex problems. The successful candidate must have interface closely with different functional organizations, including Quality Assurance teams.

This is a 40-hour per-week, 6-month contract (extensions possible), 100% onsite at the client’s office in Summit, NJ. Hours: Monday- Friday 9am-5pm

This is a W2 role as a Stage 4 Solutions employee. Health benefits and a 401K are offered.

Responsibilities

• 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.
  
  

Requirements

• Minimum 3 years of relevant work experience, preferably in a health authority regulated environment.
• Previous experience working in a biopharmaceutical manufacturing and Quality Control facility is preferred (CAR T a plus).
• Working experience of deviation investigations utilizing root cause analysis tools.
• Working experience in the CAPA process and ability to identify and verify effectiveness.
• 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.
• Ability to utilize electronic Quality systems such as eQRMs (Enterprise Quality and Regulatory Management system).
• Ability to train new team members on the investigation process
• Technical writing skills and ability to collaborate effectively in cross functional teams.
• Requires a Bachelor’s Degree in science or engineering, preferably in Biochemistry, life sciences or related engineering discipline (advanced degree preferred).
  
  

Please submit your resume to our network at https://www.stage4solutions.com/careers/ (please apply to the Quality Investigation Scientist – CAR T (Onsite – Summit, NJ) role).

Please feel free to forward this project opening to others who may be interested.

Stage 4 Solutions is an equal-opportunity employer. We celebrate diversity and are committed to providing employees with an inclusive environment that is free of discrimination and harassment. All employment decisions are based on the job requirements and candidates’ qualifications, without regard to race, color, religion/belief, national origin, gender identity, age, disability, marital status, genetic information, or other applicable legally protected characteristics.

Compensation: $52/hr. - $55.71/hr.