"All candidates must be directly contracted by ASK Consulting on their payroll and cannot be subcontracted. We are unable to provide sponsorship at this moment".
Job Title: Associate Scientist
Location: Summit, NJ
Duration: 06 Months
Pay rate: 48.95/hr on w2
100% onsite
Work Schedule: M-F- (9am - 5pm) EST
Bachelor's degree required
Duration: 6 months (possibility of extension for right candidate depending on performance)
Purpose And Scope Of Position:
- The Associate Scientist/Engineer is responsible for leading investigation reports in support.
- 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.
Required Competencies:
Knowledge, Skills, and Abilities:
- 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.
- Knowledge of data trending and tracking, including 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 Bachelors 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 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 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 ?patients 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.
- 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.
About ASK: ASK Consulting is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Consulting connects people with amazing opportunities
ASK Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all associates.