Quality System Specialist

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.