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Quality Assurance Manager

2 months ago

Johnson City, Tennessee, United States PHARMALOGIC HOLDINGS Full time
Job Title: Quality Assurance Manager

PharmaLogic Holdings is seeking a highly skilled Quality Assurance Manager to join our dynamic team. As a key member of our quality program, you will play a vital role in 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, and report and take initiative to correct safety & environmental hazards.
  • Provide immediate notification of quality-related issues to site Manager, PET Operations Management, and Q&R as necessary.
  • Oversee production operations to assure that PET drugs meet requirements for identity, strength, quality, and purity.
  • Perform PET radiopharmaceutical Quality Control (QC) in a cGMP environment and may perform aseptic processing-related tasks.
  • Responsible for quality assurance oversight of routine production, packaging, and shipping of radioisotopes.
  • Examine and approve/reject components, closures, in-process materials, packaging materials, labeling, and finished dosage forms to assure that all meet specification.
  • Assure approved vendors are used and maintain documents and records, including COA.
  • Review batch, laboratory, and production records to assure completeness, accuracy, and conformance before batch release.
  • Perform batch trending analysis and notify facility manager if any recall is necessary to assure that recalled materials are not administered to patients.
  • Initiate changes to SOPs, participate in authoring and review of SOPs, maintain documents under control in QMS, and assure SOPs match processes and procedures in PET manufacturing operations.

About PharmaLogic Holdings:

PharmaLogic Holdings is the fastest-growing SPECT & PET radiopharmaceutical solutions provider 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.