What are the responsibilities and job description for the Scientist/Engineer position at GTT, LLC?

Job Description

Job Title : Scientist / Engineer

Contract Duration : 6 Months

Pay range : $50 - 55 / hr

Location : Summit, NJ

Work Type : 100% onsite, first shift - Monday to Friday 9 am to 5 pm

Job 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.

Job Duties and 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.

The Scientist / Engineers 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 Competencies, 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).

Hands-on experience preferred with CAR-T or biopharmaceutical manufacturing and Quality Control.

Ability to train new team members on the investigation process

Required 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 3 years 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.

Benefits :

Medical, Vision, and Dental Insurance Plans

401k Retirement Fund

25-17526 : #LI-GTT #gttjobs #LI-Onsite

Company Description

We are a Native American-owned, economically disadvantaged corporation that highly values diverse and inclusive workplaces. Our clients and partners are among the most successful and innovative organizations in the world. Our top clients are Fortune 500 banking, insurance, and financial services firms, some of the nation’s largest life sciences, biotech, utility, and retail companies, and prestigious educational institutions in the Ivy League tier.

There is always a new opportunity for success when you look through all of the open job opportunities on our website’s career page. Just click on this link : https : / / bit.ly / gttcareers

Awards

SIA’s Fastest Growing Staffing Firm : 2023 and 2015

SIA’s Best Staffing Firm to Work for : 2019 -2023

Inc 5000 Fastest Growing Private Company : 2023, 2022, 2016, 2015

Randstad Preferred Supplier : 2020 - 2023

TechServe Alliance Excellence Award. 2019

NH Business Magazines Fast 5 fastest growing companies

Ernst & Young Entrepreneur of the Year Finalist : 2015

Company Description

Global Technical Talent is a subsidiary of Chenega Corporation (www.Chenega.com) with over 1.3 billion US$ in revenue and 5800 US employees. We provide Total Talent Solutions, Global staffing, SOW, RPO, Direct Sourcing, and Global Payroll with physical offices in US, Canada, and India. GTT Digital headquartered in Toronto specializes in providing high-tech digital and banking talent to some of the nation’s largest financial institutions. As a leader in the staffing industry for over 22 years, we have become one of the largest staffing firms in the New England region, working with Fortune 500 clients and cutting-edge, technology-driven recruiting infrastructure. We are a Native American-owned, economically disadvantaged corporation that highly values diverse and inclusive workplaces. Our clients and partners are among the most successful and innovative organizations in the world. Our top clients are Fortune 500 banking, insurance, and financial services firms, some of the nation’s largest life sciences, biotech, utility, and retail companies, and prestigious educational institutions in the Ivy League tier. There is always a new opportunity for success when you look through all of the open job opportunities on our website’s career page. Just click on this link : https : / / bit.ly / gttcareers Awards SIA’s Fastest Growing Staffing Firm : 2023 and 2015 SIA’s Best Staffing Firm to Work for : 2019 -2023 Inc 5000 Fastest Growing Private Company : 2023, 2022, 2016, 2015 Randstad Preferred Supplier : 2020 - 2023 TechServe Alliance Excellence Award. 2019 NH Business Magazines Fast 5 fastest growing companies Ernst & Young Entrepreneur of the Year Finalist : 2015

Salary : $50 - $55

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