What are the responsibilities and job description for the QC Investigations Scientist - CAR T-Biopharma Manufacturing (Onsite-Summit, NJ) position at Stage 4 Solutions Inc?
QC Investigations Scientist - CAR T-Biopharma Manufacturing (Onsite-Summit, NJ)
We are seeking a QC Investigations Scientist - CAR T- Biopharma Manufacturing for a global pharmaceutical company. 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.
This is a 40-hour per-week, 6-month contract (extensions possible), 100% onsite role in Summit, NJ.
This is a W2 role as a Stage 4 Solutions employee. Health benefits and 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.
- Initiate change control documentation. Identify functional area SMEs to perform impact assessments as part of the change management process.
- Provide technical support for manufacturing investigations / CAPAs / change controls as needed. Serve as author or technical reviewer of departmental procedures as appropriate.
- Support deviation investigation defense during audits and site inspections for QC compliance related inquiries. Provide training to new investigations team members
- 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 :
Please submit your resume to our network at https : / / www.stage4solutions.com / careers / (please apply to the QC Investigations Scientist - CAR T-Biopharma Manufacturing (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 : $50 / hr. - $55.95 / hr.
LI-SW1
Salary : $50 - $56
