Quality Assurance Engineer

Company Info
Radnor, PA, United States

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Company Profile


Quality Assurance Engineer


Sanborn, NY 

Job ID:


Job Description:

The Quality Assurance Engineer (Biopharma/Chemicals) is responsible for quality assurance activities, with oversight of investigations, root cause analysis, validations, quality procedures, and continuous improvements.

Location: Position will be onsite in Sanborn, NY


  • Use Quality Engineering principles, tools, and techniques to develop and optimize systems and processes so that they are aligned with company strategy and regulatory requirements.
  • Perform root cause analysis, identify and implement corrective actions for non-conformances and customer complaints
  • Review and approve quality assurance documents – risk assessments, validation protocols/reports, change managements records, CAPAs, Non-conforming material reports, trend reports.
  • Collect, review, and interpret data for trend reporting, metrics, quality system review and complaints.
  • Responsible for managing Quality System programs, including calibration and environmental monitoring.
  • Responsible for continual improvement activities to enhance the Quality System.
  • Develops and performs training to build quality awareness throughout the company.
  • Collaborate with Manufacturing, Research and Development and Engineering to ensure transfer of newly developed products in accordance with approved data and analysis.
  • Conducts audits (internal and supplier) to monitor compliance with ISO 9001:2015, including creating audit finding reports, working with multi-functional teams to determine and implement proper corrective and preventive action, and closing out audit findings.
  • Assists in creation and maintenance of quality documentation.
  • Evaluate impact of process improvement efforts and manufacturing deviations on process validation.
  • Demonstrates good communication and project management skills.
  • Collaborate with team members to support company goals.


  • Bachelor’s degree required in a natural/life science field with proficiency in one of the following areas: Chemistry, Biology, Microbiology, or cell culture; or an equivalent combination of education, certification, and experience
  • Minimum 3 – 5 years’ experience in a quality engineering role, in a manufacturing facility preferred
  • Working knowledge of problem-solving tools and Root Cause Analysis.
  • Proven Understanding of ISO 9001:2015.
  • Process Validation or cleaning validation experience desired.
  • Work experience in Chemical or Biopharma Industry preferred.


  • ASQ Certified Quality Engineer, or ASQ Certified Quality Auditor or currently pursuing certification preferred.
  • Can work independently and optimally in a team environment.
  • Can identify problems and communicate solutions in a constructive and positive manner.
  • Attention to detail; excellent organizational and record keeping skills. 
  • Excellent Technical Writing/ Report writing skills.
  • Working knowledge and experience with LEAN, Six Sigma methodologies.