Summit,
NJ
07901
US
Posted: 09/05/2023
2023-09-05
2023-10-31
Job Number: 24901021
Job Description
QC ENGINEER
SUMMIT, NJ
100% onsite.
The pay ranges between $60.74 - $62.98 per hour.
Project Description:
- The Scientist/Engineer is 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 incumbent must interface closely with different functional organizations, including Quality Assurance teams.
- 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.
Required Skills:
- Requires a Bachelor's Degree in science or engineering, preferably in Biochemistry, life sciences or related engineering discipline (advanced degree preferred).
- Minimum 3 years of relevant work experience, preferably in a health authority regulated environment.
- An equivalent combination of education and experience may substitute.
- Working experience of 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, apply Global Regulatory and cGMP requirements.
- Ability to support health authority inspections.
- 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 CAR-T or biopharmaceutical manufacturing and Quality Control.
- Ability to train new team members in the investigation process.
- Previous experience working in a biopharmaceutical manufacturing facility is preferred (CAR T a plus).
- Knowledge of data trending and tracking, including use of statistical analysis software a plus.
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 #23-01483
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE
#LI-RM1
#LI-Onsite
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