Pharmaceutical Quality Assurance Specialist

6 days ago


Southlake, Texas, United States FARMAKEIO OUTSOURCING Full time
Job Title: Pharmaceutical Quality Assurance SpecialistAbout the Role

FarmaKeio Outsourcing, an FDA-registered 503B outsourcing facility, is seeking a skilled Pharmaceutical Quality Assurance Specialist to ensure the quality, safety, and efficacy of compounded sterile preparations.

The ideal candidate will have at least 2-5 years of experience in sterile compounding, QC testing, or related pharmacy fields. A PharmD or BS in Pharmacy degree is required, with current licensure in the state of Texas.

Key Responsibilities
  • Oversee the testing results of compounded sterile products to ensure compliance with federal regulations and facility standards.
  • Conduct visual inspection, sterility testing, endotoxin testing, potency testing, and other relevant analytical tests.
  • Ensure proper documentation of quality control activities, including deviations, investigations, and corrective actions.
Required Skills and Qualifications
  • In-depth understanding of USP , USP , and other related pharmaceutical compounding standards.
  • Familiarity with FDA regulations, cGMP, and quality assurance practices.
  • Strong analytical, problem-solving, and critical thinking abilities.
Benefits and Other Information

The salary for this position is estimated to be between $120,000 and $145,000 per year. The job is typically performed in a sterile compounding facility or pharmaceutical lab setting, and may require working with specialized equipment, chemicals, and materials in a regulated environment.



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