Associate Scientist

2 weeks ago

Akron, Ohio, United States Artech LLC Full time

Position Title: Associate Scientist - Quality Assurance Specialist

Location: Summit, NJ

Work Schedule:
Wednesday to Saturday (7am-5pm) EST

Essential Qualifications:
  • A Bachelor's Degree in a relevant field such as Science or Engineering, preferably in Biochemistry or life sciences (advanced degree is a plus).
  • At least 1 year of pertinent experience in a regulated environment.
  • Experience in a biopharmaceutical manufacturing setting is advantageous, particularly with CAR T.
  • Proficient in conducting deviation investigations using root cause analysis methodologies.
  • Familiarity with the CAPA process and capability to assess and confirm effectiveness.
  • Strong technical writing skills and ability to collaborate effectively across various teams.
  • Demonstrated understanding of Global Regulatory and cGMP standards.
  • Capacity to assist during health authority inspections.
  • Knowledge in data analysis and tracking, including statistical software.
  • Proven problem-solving skills and logical reasoning abilities.
  • Competence in prioritizing tasks, managing timelines, and adapting to changing priorities.
  • Ability to work collaboratively with management and support organizational objectives.
  • Effective communication skills with peers and management.
  • Experience with electronic Quality systems such as eQRMs or Infinity is preferred.
  • Hands-on experience in CAR-T or biopharmaceutical manufacturing and Quality Control is desirable.

Role Overview:
The Associate Scientist/Engineer will take charge of leading investigation reports in support of CAR T operations. This role encompasses executing comprehensive root cause investigations, interviewing staff, testing hypotheses, interpreting findings, authoring investigation reports, and identifying corrective and preventive actions (CAPA). The successful candidate will work closely with various functional teams, particularly Quality Assurance.

Key Responsibilities:
  • Conduct in-depth investigations (Environmental Monitoring, deviations, etc.) using root cause analysis tools.
  • Lead cross-functional investigation teams and ensure timely closure of reports.
  • Perform GEMBA walks with stakeholders to gain insights into process steps and evaluate root causes.
  • Collaborate with functional teams to propose effective CAPAs and develop plans to ensure their effectiveness.
  • Assess potential impacts and risks associated with changes and develop appropriate mitigation strategies.
  • Initiate change control documentation as necessary.
  • Identify subject matter experts to conduct impact assessments during the change management process.
  • Ensure timely completion of all investigations and promptly notify stakeholders of any delays.
  • Provide technical support for manufacturing investigations, CAPAs, and change controls as required.
  • Support investigation defense during audits and site inspections.
  • Address complex issues and resolve problems with minimal guidance.
  • Serve as an author or technical reviewer for departmental procedures as appropriate.
  • Apply lean manufacturing and six sigma principles to enhance products, processes, and systems.
  • Continuously support the mission of prioritizing patient needs and fostering a 'Right First Time' mindset.

Working Environment:
  • 80% to 90% of the time will be spent in an office setting.
  • 10% to 20% of the time will be in a manufacturing or laboratory environment.
  • Flexibility to work extended hours, weekends, and holidays may be required to meet project deadlines.

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