Sr. GDP Operational Quality Specialist

1 month ago


Boston, United States Hydrogen Group Full time

Location: Boston, MA (onsite Fan Pier)

Schedule: Standard Office Hours

Duration: 12-Month Contract (chance to extend)

Pay range: $55.00 - $62.00 per hour

The Quality Senior Specialist will work with the GDP Operational QA Management team to ensure the distribution of medicines in the USA complies with GDP and GMP requirements. They will oversee Third Party Logistics providers and support key stakeholders within the organization.

Key responsibilities include:

  • Managing and maintaining Quality Agreements, KPIs, deviations, CAPAs, and change controls.
  • Overseeing Finished Goods release at 3PL and ensuring compliance with distribution requirements.
  • Supporting New Product Launches, Clinical QA distribution, recalls, and market activities.
  • Providing regulatory inspection support and post-inspection follow-ups.
  • Managing event investigations, CAPAs, and customer complaints.
  • Maintaining the Quality Management System (QMS) and ensuring compliance with regulations and licensing.
  • Engaging in self-inspections and approving subcontracting activities.
  • Creating and approving Standard Operating Procedures (SOPs) and quality documents.

Qualifications:

  • Master's degree with 3-5 years or Bachelor's degree with 5+ years of relevant experience.
  • Strong background in GDP/GMP, auditing, interpersonal skills, and fluency in English.
  • Proficiency in Microsoft Office is required.



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