Title: Sr Specialist, GDP Operational QA
Location: Boston, MA (Hybrid)
Employment Type: Contract (12+ Months)
Status: Accepting Candidates
About the role
Join a Quality Assurance team supporting distribution and logistics operations to ensure compliance with GDP and GMP requirements. This role focuses on providing day-to-day Quality oversight of third-party logistics providers and supporting distribution-related Quality Management System activities.
The ideal candidate will have strong experience in GDP environments, distribution quality, and supply chain compliance.
Key Responsibilities
- Provide Quality oversight of third-party logistics (3PL) distribution partners
- Support preparation and maintenance of Quality Agreements
- Review and support resolution of deviations, CAPA, and change controls
- Maintain and track key performance indicators (KPIs) related to distribution activities
- Support release of finished goods at third-party logistics locations
- Analyze compliance issues and escalate risks when necessary
- Maintain Quality Management System (QMS) documentation related to distribution operations
- Support product recalls and mock recall activities
- Participate in GDP Management Review activities
- Support new product launch activities related to distribution requirements
- Assist with regulatory inspections and audit readiness activities
- Ensure distribution licenses remain compliant and updated
- Participate in distribution expansion and Quality improvement projects
Qualifications
- Master’s degree with 3–5 years of relevant Quality experience,
- OR
- Bachelor’s degree in a scientific or allied health field with 5+ years of relevant experience
- 5+ years of experience working in a Quality role
- Strong experience working in GDP (Good Distribution Practice) environments
- Experience supporting distribution, logistics, or supply chain Quality operations
- Experience supporting 3PL oversight
- Experience reviewing deviations, CAPA, and change controls
- Strong knowledge of GDP and GMP regulations
- Experience working with Quality Management Systems (QMS)
- Strong attention to detail and documentation review skills
- Strong communication and stakeholder collaboration skills
Preferred Qualifications
- Experience supporting finished goods release
- Experience supporting distribution licenses and regulatory compliance
- Experience supporting new product launch distribution activities
- Experience supporting recall and mock recall programs
- Experience supporting regulatory inspections
- Experience working in pharmaceutical or biotechnology environments
Compensation
- Estimated hourly range: $50–$60/hr (W-2)
- Final rate within this range will be based on skills, experience, and interview results.
- Work Schedule: Hybrid – Boston, MA
