Associate Scientist

2 weeks ago

Akron, Ohio, United States Artech LLC Full time

Position: Associate Scientist - Quality Assurance Specialist
Location: Summit, NJ
Work Schedule: Wed-Sat (7am-5pm) EST

Qualifications Required:
  • 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.
  • Familiarity with biopharmaceutical manufacturing, particularly CAR T processes, is advantageous.
  • Proficient in conducting deviation investigations using root cause analysis methodologies.
  • Experience with the CAPA process and the ability to assess and verify effectiveness.
  • Strong technical writing capabilities and effective collaboration within cross-functional teams.
  • In-depth understanding of Global Regulatory and cGMP standards.
  • Capability to assist during health authority inspections.
  • Knowledge of data analysis and tracking, including statistical software usage.
  • Demonstrated problem-solving skills and logical reasoning.
  • Ability to prioritize tasks, manage timelines, and adapt to changing priorities.
  • Effective communication skills with peers and management.
  • Familiarity with electronic Quality systems such as eQRMs or Infinity.
  • Hands-on experience in CAR-T or biopharmaceutical manufacturing and Quality Control is preferred.

Role Overview:
The Associate Scientist is tasked with leading investigation reports to support CAR T operations. This role involves 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 detailed investigations (e.g., Environmental Monitoring, deviations) using root cause analysis tools.
  • Lead cross-functional investigation teams and ensure timely closure of reports.
  • Perform GEMBA walks with stakeholders to enhance understanding of processes and evaluate root causes.
  • Collaborate with functional teams to propose effective CAPAs and develop plans to ensure their effectiveness.
  • Assess the potential impact and risks associated with changes and develop mitigation strategies.
  • Initiate change control documentation as necessary.
  • Identify subject matter experts for impact assessments during change management.
  • Ensure timely completion of all investigations and communicate any delays promptly.
  • Provide technical support for manufacturing investigations, CAPAs, and change controls as required.
  • Support investigation defenses during audits and site inspections.
  • Address complex issues and resolve problems with minimal supervision.
  • Serve as an author or technical reviewer for departmental procedures as needed.
  • 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 Conditions:
  • Primarily office-based (80% to 90% of the time).
  • Occasional work in manufacturing or laboratory settings (10% to 20% of the time).
  • Flexibility to work extended hours, weekends, or holidays may be required to meet deadlines.

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