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Quality System Specialist

Woburn $65 - $80 p/h Contract

Responsibilities

  • Support and oversee Quality Management System (QMS) activities, including Change Controls, Deviations, Investigations, CAPAs, and audit readiness.
  • Partner with site and global leadership teams to ensure compliance with quality system requirements and communicate critical quality issues to management.
  • Coordinate revisions and maintenance of quality system SOPs, forms, templates, and related documentation.
  • Monitor weekly and quarterly quality metrics and support Quality Management Review activities.
  • Drive actions to resolve quality issues and maintain a state of control across operations.
  • Provide guidance and support for deviations, investigations, change controls, risk assessments, and CAPAs.
  • Collaborate with cross-functional teams including Quality, Manufacturing, Pharmaceutical Development, Regulatory Affairs, Quality Control, and Program Management.
  • Manage multiple priorities and ensure departmental and organizational timelines are met.
  • Promote a culture of quality, compliance, and continuous improvement.
  • Support additional quality systems activities and projects as assigned.

Qualifications

  • Bachelor's degree in a scientific discipline required.
  • 1–3 years of experience in the pharmaceutical or medical device industry.
  • Experience working within cGMP-regulated quality systems.
  • Experience supporting or managing Change Controls, Deviations, Investigations, CAPAs, and quality documentation.
  • Experience writing and revising SOPs and controlled documents.
  • Familiarity with Supplier Notification of Changes and Supplier Corrective Action Requests (SCARs) preferred.
  • Strong understanding of GMP requirements; GLP and GCP knowledge is a plus.
  • Ability to work independently in a fast-paced environment.
  • Strong organizational skills with exceptional attention to detail.
  • Excellent written, verbal, and presentation communication skills.
  • Proven ability to collaborate effectively with cross-functional teams and senior leadership.
  • Ability to manage competing priorities and meet deadlines.
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