Quality Engineer Pharmaceutical Manufacturing

Easton, PA, US • Posted 6 hours ago • Updated 6 hours ago
Contract W2
Contract Independent
On-site
Depends on Experience
Fitment

Dice Job Match Score™

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Job Details

Skills

  • Quality Engineer Pharmaceutical Manufacturing
  • cGMP
  • ICH Q7
  • IPEC
  • ISO
  • FDA
  • CAPA
  • complaint investigations
  • validation
  • stability
  • SPC
  • quality systems
  • pharmaceutical
  • biotechnology
  • chemical
  • regulated environments

Summary

< class="isSelectedEnd">Quality Engineer Pharmaceutical Manufacturing

We are seeking an experienced Quality Engineer to lead quality assurance programs, regulatory compliance, and continuous improvement initiatives within a regulated manufacturing environment.

Key Responsibilities
  • Develop and implement quality programs aligned with cGMP, ICH Q7, IPEC, ISO, and FDA requirements.
  • Support and manage CAPA, complaint investigations, validation, stability, SPC, and quality systems.
  • Lead root cause analysis, corrective actions, defect prevention, and process improvement initiatives.
  • Manage supplier, customer, internal, and regulatory audits.
  • Partner with customers to investigate and resolve quality complaints and inquiries.
  • Develop and improve testing, inspection, validation, and quality control processes.
  • Analyze quality data and implement solutions to improve product quality and compliance.
  • Collaborate cross-functionally to maintain and continuously improve quality systems.
Must-Have Qualifications
  • 5+ years of experience in Quality Engineering or a related role.
  • Experience in pharmaceutical, biotechnology, chemical, or similarly regulated environments.
  • Hands-on experience in cGMP and ISO 9000 regulated environments.
  • Strong knowledge of quality systems, CAPA, investigations, validation, and audit processes.
  • Strong analytical, problem-solving, and communication skills.
  • Experience working with customers, suppliers, and regulatory stakeholders.
Education
  • Bachelor s degree in Chemistry or a related field required.
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
  • Dice Id: 10439527
  • Position Id: 9059881
  • Posted 6 hours ago
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