Sr. Compliance Specialist, Systems
EPM Scientific · Portsmouth, NH · 2 wk ago
Quality Assurance$118k/yrFull-time
Key Responsibilities
- Support and maintain Quality Management System (QMS) activities
- Drive compliance initiatives and quality system improvements
- Support regulatory inspections and customer audits
- Participate in inspection readiness activities and remediation efforts
- Partner with cross-functional teams to ensure GMP compliance
- Auxiliary with CAPAs, change controls, deviations, and quality system records as needed
- Analyze trends and identify opportunities for continuous improvement
- Lead and support quality-focused projects across multiple functional areas
- Serve as a subject matter resource for compliance and quality systems activities
Desired Background
- 5+ years of Quality Assurance, Compliance, or Quality Systems experience within the pharmaceutical industry
- Strong understanding of cGMP regulations and quality systems
- Experience supporting FDA, customer, or regulatory inspections
- Background in audit management, inspection readiness, or compliance programs
- Experience working within electronic quality management systems (eQMS)
- Strong communication skills with the ability to influence across departments
- Self-starter who can manage multiple priorities and work independently
- Comfortable in a fast-paced, highly collaborative environment
Compensation & Schedule
- Up to $118,000 base salary
- 10% annual bonus
- Full-time, onsite position
- Monday-Friday schedule