Title: Senior QA Specialist – GDP / Distribution / 3PL
Location: Greater Boston Area, MA (Hybrid 2–3 days onsite)
Employment Type: Contract
Status: Accepting Candidates
About the role
This role supports quality oversight of pharmaceutical distribution operations, ensuring compliance with GDP and GMP standards. You will work closely with internal stakeholders and external partners to maintain quality across supply chain and logistics activities.
Key Responsibilities
- Oversee 3PL partners to ensure compliance with GDP and distribution requirements
- Maintain and support the QMS, including deviations, CAPA, and change controls
- Review and manage Quality Agreements, KPIs, and compliance metrics
- Support finished goods release and on-market activities including recalls
- Participate in regulatory inspections, audits, and GDP management reviews
- Support new product launches with distribution quality requirements
Qualifications
- 5+ years of experience in a Quality role within pharma/biotech
- Strong knowledge of GDP, GMP, and distribution/supply chain operations
- Hands-on experience with QMS, deviations, CAPA, and change control
- Experience managing 3PL or external logistics partners
- Bachelor’s degree in a scientific or allied health field (or equivalent experience)
- Experience supporting audits, inspections, and regulatory compliance
Compensation (MA Pay Transparency):
- Estimated hourly range: $50–$60/hr (W-2).
- Final rate within this range will be based on skills, experience, and interview results.
