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Company

Original Job Post

LanceSoft, Inc. · 2 days ago

Associate Scientist - Engineering

Summit, NJ

Full-time

Onsite

Entry, Mid Level

1+ years exp

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Information Technology

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Responsibilities

Conduct thorough investigations utilizing root cause analysis tools.

Lead investigations and cross functional teams, and close reports promptly.

Work with stakeholders to propose effective CAPAs and assess potential impacts of changes.

Initiate change control documentation and support deviation investigation defense during audits.

Employ lean manufacturing principles to improve products, processes, and systems.

Qualification

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Root cause analysisCAPA processTechnical writingRegulatory complianceHealth authority inspections supportData trendingStatistical analysis softwareProject managementQuality systems utilizationProblem-solvingCollaborationLogical thinkingTime managementCommunicationBiopharmaceutical ManufacturingQuality ControlCAR-T

Required

Bachelor's degree in science or engineering, preferably in Biochemistry, life sciences or related engineering discipline

Minimum 1 year of relevant work experience, preferably in a health authority regulated environment

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

Preferred

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

Previous experience working in a biopharmaceutical manufacturing facility is preferred (CAR T a plus)

Company

LanceSoft, Inc.

Glassdoor

4.1

Established in 2000, LanceSoft is a Certified MBE and Woman-Owned organization, and a pioneer in providing premium end-to-end Global Workforce Solutions and IT Services to diverse clients across various domains.

Founded in 2000

Herndon, Virginia, USA

1,001-5,000 employees

http://www.lancesoft.com/

H1B Sponsorship

LanceSoft, Inc. has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Trends of Total Sponsorships

2023 (20)

2022 (22)

2021 (46)

2020 (69)