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Quality Pharmacist Specialist

1 month ago

Southlake, Texas, United States FARMAKEIO OUTSOURCING Full time
Job Title: Quality Pharmacist

As a key member of the Quality Unit at FarmaKeio Outsourcing (FKO), the Quality Pharmacist plays a crucial role in ensuring the accuracy and completeness of products manufactured at FKO. This involves establishing and approving documentation, reviewing quality data, and reporting on the implementation of the Quality Management System.

Key Responsibilities:
  • Perform and/or coordinate completion of environmental monitoring and documentation, including personnel monitoring, air bioburden, surface bioburden, temperatures, and particle counts.
  • Collect environmental monitoring samples as necessary and train new Quality Unit staff.
  • Record sterility testing results, aseptic technique qualifications, and media fill process validations.
  • Prepare and revise operating procedures and specifications, as well as review and approve routine change control requests.
  • Verify that raw materials meet specifications limits and oversee control of product labeling/label accountability.
  • Recommend and implement improvements in streamlining processes and procedures in the areas of compounding, validation, change control, laboratory, and risk assessments.
  • Use incident and Corrective and Preventive Action (CAPA) activities and processes to drive quality improvements and respond to process and service issues.
Requirements:
  • Bachelor of Science in Pharmacy or Pharm.D. with registration in good standing and current pharmacist license in the state of Texas.
  • Ability to work autonomously within established procedures and practices.
Work Environment:

Climate-controlled office environment.

Knowledge and Skills:
  • Working knowledge of Current Good Manufacturing Practices (cGMPs), FDA regulations (21 CFR Parts 210, 211), and ICH regulations.
  • Effective communication skills, both written and verbal.
  • Ability to act effectively as a member of a team to resolve problems.
Physical and Special Requirements:
  • Ability to stand for prolonged periods of time.
  • May need to lift up to 40 pounds.

Compensation: $120,000 - $140,000 yearly.