503b Qc Pharmacist

Company: FARMAKEIO OUTSOURCING
Location: Flower Mound
Posted on: February 19, 2025

Job Description:

A 503B Quality Control (QC) Pharmacist is responsible for ensuring the quality, safety, and efficacy of compounded sterile preparations (CSPs) in a 503B outsourcing facility. These facilities are registered with the U.S. Food and Drug Administration (FDA) and are authorized to compound drugs in bulk for distribution. The QC pharmacist's role involves overseeing the testing, validation, and quality assurance processes required for compliance with federal regulations and facility standards.

Responsibilities:
Quality Control Testing:
--- Oversee the testing results of compounded sterile products to ensure they meet the required quality standards.
--- Conduct visual inspection, sterility testing, endotoxin testing, potency testing, and other relevant analytical tests.
--- Ensure all testing procedures adhere to USP , USP , and other applicable standards.

Documentation and Compliance:
--- Review and maintain batch records, certificates of analysis (COAs), and test results.
--- Ensure proper documentation of quality control activities, including deviations, investigations, and corrective actions.
--- Assist with regulatory audits and inspections, ensuring that the facility is compliant with FDA, USP, and state pharmacy board regulations.

Validation and Qualification:
--- Support or lead validation efforts for equipment, processes, and systems in the quality control lab.
--- Participate in equipment qualification, method validation, and re-validation processes to ensure consistency and reliability in testing.
--- Review and approve validation protocols and reports.

Risk Assessment and Continuous Improvement:
--- Conduct risk assessments to identify potential quality issues related to compounding and manufacturing processes.
--- Recommend and implement corrective and preventive actions (CAPA) for identified quality problems.
--- Collaborate with other departments (compounding, production, and regulatory affairs) to improve overall product quality.

Training and Mentorship:
--- Provide guidance and training to QC personnel, pharmacy technicians, and other staff regarding quality control procedures and regulations.
--- Ensure the QC team is up to date on current Good Manufacturing Practices (cGMP), USP standards, and FDA guidelines.

Equipment and Facility Maintenance:
--- Oversee environmental monitoring of the facility, ensuring conditions such as temperature, humidity, and sterility are maintained according to required standards.

Regulatory and Safety Oversight:
--- Stay updated on new FDA regulations, USP guidelines, and other relevant industry standards.
--- Implement and enforce safety protocols in the laboratory and production areas to ensure compliance with safety regulations.

Qualifications:
Education: PharmD or BS in Pharmacy (Doctor of Pharmacy preferred).
Licensure: Current pharmacist licensure in the state of Texas.
Experience:
--- At least 2-5 years of experience in sterile compounding, QC testing, or related pharmacy fields.
--- Experience working in a 503B outsourcing facility, hospital pharmacy, or manufacturing setting preferred.

Knowledge:
--- In-depth understanding of USP , USP , and other related pharmaceutical compounding standards.
--- Familiarity with FDA regulations, cGMP, and quality assurance practices.

Skills:
--- Strong analytical, problem-solving, and critical thinking abilities.
--- Excellent attention to detail and organizational skills.
--- Ability to work independently and as part of a team.
--- Strong communication skills to interact with cross-functional teams, regulatory bodies, and management.

Work Environment:
--- The job is typically performed in a sterile compounding facility or pharmaceutical lab setting.
--- The role may require working with specialized equipment, chemicals, and materials in a regulated environment.

Key Competencies:
--- Quality control and assurance.
--- Regulatory compliance.
--- Analytical testing and documentation.
--- Risk management and corrective actions.
--- Staff training and development.

About Company:
FarmaKeio Outsourcing is an FDA-registered 503B outsourcing facility that manufactures bioidentical hormone pellets in a clean, controlled environment. As a leader in the field of 503B pharmaceutical services, we focus on offering high-quality and timely compounded medications while adhering to strict regulatory expectations. We believe in the power of collaboration, integrity, and service to ensure that each patient receives the best care possible.

Keywords: FARMAKEIO OUTSOURCING, Flower Mound , 503b Qc Pharmacist, Healthcare , Flower Mound, Texas