Associate Scientist (Biochemistry, CAPA)

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Job description

On-Board Scientific is hiring a Associate Scientist (Biochemistry, CAPA) in Summit, NJ

For immediate consideration please send your resume to

Subject Line: Position Title and State you are located

About Us:

On-Board Services, Incorporated is an on-site contract service provider for a local manufacturing entity providing full time positions to our employees. We offer benefits as well as 401k.

Position Details:

Title: Associate Scientist (Biochemistry, CAPA)

Position Type: 6 month contract with additional opportunity contingent upon performance and continued business need

Job Location: Summit, NJ

Shift: Wednesday - Saturday 4PM-2AM

Compensation:

Responsibilities:

The Associate Scientist/Engineer is responsible for leading investigation reports in support of S12 CAR T operations. This includes execution of thorough root cause investigations, interviewing personnel, 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.

Qualifications:

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

• Requires a Bachelor's Degree in science or engineering, preferably

in Biochemistry, life sciences or related engineering discipline (advanced

degree preferred).

Apply Today!

On-Board was founded in 1976 by Robert L. Wilson to provide Engineering and Design services to the chemical manufacturing industry. Today, On-Board is a thriving privately held family of companies with services including: Consulting, Professional Engineering, Industrial Maintenance and Facility Management, Contracted Manufacturing and Production Services, as well as Temporary Staffing and Recruiting throughout North America.

The On-Board Family of Companies conducts operations through its Corporate Headquarters located in East Windsor, NJ along with Regional Offices in New Castle, DE and Wake Forest, NC. On-Board's Mission is to provide "Flexible Service by applying the talents of our people, work processes and technology to meet our clients' expectations in a Safe, Responsible and Dependable manner."

On-Board Companies provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, religion, sex, national origin, age, disability or genetics.

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