Quality Assurance Pharmacist

FARMAKEIO Pharmacy Network•Southlake, TX

About The Position

At FarmaKeio Outsourcing, we’re reshaping the idea of healthcare. We believe medicine should go beyond masking symptoms to uncover and treat the root cause. Every formula we create is designed to restore balance, vitality, and the freedom to live well. This role requires a profound commitment to detail. You will be meticulously reviewing production activities and documentation as part of the Quality Unit. Ensuring medications designed to restore individual balance and vitality are produced according to the highest quality standards. This precision is the foundation of the patient’s comeback story. Job Summary This role performs independent quality oversight and batch disposition activities, and leads or supports core quality systems (deviations/nonconformances, OOS/OOT, change control, CAPA, complaints/recalls, validation/qualification, supplier/material quality, and inspection readiness) to maintain compliance with FD&C Act 503B requirements, applicable USP standards, and cGMP (21 CFR Parts 210/211).

Requirements

Valid Pharmacist License
Must meet legal and regulatory requirements for handling-controlled substances, including passing a background check and drug screening as required by applicable laws.
Strong analytical, problem-solving, and critical thinking abilities.
Excellent attention to detail and organizational skills.
Ability to work independently and collaboratively as part of a team.
Effective communication skills for engaging with cross-functional teams, regulatory bodies, and management.
Proven ability to analyze complex data and troubleshoot effectively.
Skilled in maintaining accurate and precise documentation to ensure data integrity.
Proficient in operating and maintaining laboratory instruments and software.
Commitment to staying current with emerging technologies and industry advancements
U.S. College Degree in Pharmacy (example: PharmD (Doctorate of Pharmacy))
Current active pharmacist licensure in the state of Texas.
Familiarity with FDA regulations, cGMP, and quality assurance practices.

Nice To Haves

Experience in a 503B outsourcing facility, or manufacturing setting preferred.

Responsibilities

Oversee environmental monitoring, air and surface bioburden, temperatures, and particle counts.
Collect and document environmental monitoring samples and results.
Submit samples for testing.
Review and maintain batch records, and product test results.
Review quality records, including equipment calibration, maintenance logs, and cleanroom records.
Support, as needed, other quality documentation requirements.
Support validation and qualification efforts for equipment, processes, and systems.
Perform final review of test data and reports; approve or reject product batches as per established standards.
Assist with root cause analysis and recommend corrective and preventive actions (CAPA) for quality-related issues, including deviations, complaints, and audit findings.
Use CAPA processes to drive quality improvements and respond to process or service issues.
Ensure compliance with USP <797>, USP <800>, FDA regulations, and cGMP standards for all quality processes.
Assist with regulatory audits, inspections, and compliance reporting.
Collaborate with other departments to identify and implement process improvements in compounding, validation, and laboratory operations.
Implement and enforce safety protocols in laboratory and production areas to maintain compliance.
Oversee control of product labeling and ensure label accountability.
Support training and qualification programs as needed.
Promote a culture of quality and patient safety through proactive communication and escalation of quality risks.
Employees must adhere to all OSHA safety standards to ensure a safe working environment, including proper use of personal protective equipment (PPE) and adherence to infection control procedures.
Safeguard patient confidentiality in compliance with HIPAA guidelines, ensuring that all patient data is handled securely and appropriately.
Maintain a commitment to continuing education to stay updated on best practices and innovations in the field.