Senior Quality Assurance Specialist

1 week ago


Johnson City, Tennessee, United States PHARMALOGIC HOLDINGS Full time
Pharmalogic Holdings - Quality Assurance Manager Position

Estimated salary: $80,000 - $110,000 per year.

About Us

Pharmalogic Holdings is a leading provider of SPECT & PET radiopharmaceutical solutions and contract development and manufacturing organization (CDMO) with radiopharmacies across North America. We are passionate about expanding the power of radiopharmaceutical technology to provide transformative diagnostic and therapeutic agents to patients from bench to bedside.

About the Role

We are seeking an experienced Quality Assurance Manager to join our dynamic team. The successful candidate will be responsible for ensuring compliance with cGMP and other regulatory standards for the manufacture of drugs for administration to patients.

Key Responsibilities
  • Ensure compliance with all regulatory commitments and company policies and SOPs, including cGMP and radiation safety.
  • Actively promote adherence to SOPs, as well as safety rules and awareness.
  • Provide immediate notification of quality-related issues to site management, PET operations management, and Q&R as necessary.
  • Oversee production operations to ensure that PET drugs meet requirements for identity, strength, quality, and purity.
Requirements
  • Excellent knowledge of cGMP and regulatory requirements.
  • Experience in a quality assurance role, preferably in a pharmaceutical or biotechnology company.
  • Strong communication and leadership skills.
  • Ability to work effectively in a team environment.
What We Offer
  • A competitive salary range of $80,000 - $110,000 per year.
  • A comprehensive benefits package, including health insurance, retirement plan, and paid time off.
  • The opportunity to work with a dynamic and growing company.


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