Quality Systems Specialist

SGS_JOB_3335

Business Support
 Pennsylvania
Quality Systems
cGMP Compliance
SOP Writing & Revision
Inspection Readiness
Quality Metrics
Document Control
eQMS
Cross-functional Collaboration

Contract - 12 Months + Possible Extension

Location: Exton, PA 19341. The Quality Systems Specialist will support and maintain regional quality systems in a cGMP-regulated environment. This role focuses on SOP management, inspection readiness, quality metrics reporting, and continuous improvement of quality processes while collaborating with cross-functional teams onsite.

Job Responsibilities:

  • Perform core quality systems activities including SOP revisions and inspection readiness support
  • Develop, improve, and maintain regional Quality System SOPs
  • Analyze, track, and report quality and risk metrics and drive corrective actions
  • Identify gaps within quality systems and escalate issues appropriately
  • Support project management initiatives within the quality systems function
  • Collaborate with cross-functional teams to ensure quality compliance and outcomes

Skills:

  • Strong knowledge of cGMP regulations and quality systems
  • Experience with SOP writing, document control, and quality metrics
  • Hands-on experience with electronic quality systems (eQMS)
  • Strong communication and stakeholder management skills
  • Ability to identify risks, escalate issues, and drive resolution

Education/Experience:

  • Bachelor’s degree in Chemistry, Biochemistry, or equivalent technical discipline
  • 3–5 years of experience in Quality Systems within a regulated (cGMP) environment
  • Experience supporting audits, regulatory inspections, training systems, or document control
  • Proven performance in prior quality or compliance roles

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