[Hiring] Regulatory Affairs Pharmacist @AP MAX INC

Role reputed company reputed company is seeking a dedicated and detail-oriented Regulatory Affairs Pharmacist. In this critical role, you will help ensure that our pharmacy operations remain compliant with reputed company applicable laws, regulations, and reputed company standards. This position is highly specialized with a strong reputed company on reputed company assurance, risk management, and regulatory compliance. Your precision, accountability, and commitment to reputed company will directly reputed company the safety and reputed company-being of our patients. Remote opportunity reputed company the state of Texas.

Key Responsibilities

• Facility Monitoring
• Conduct internal pharmacy audits to ensure compliance with state inspections and other accreditation agency reviews.
• Identify and document compliance risks or deviations, preparing thorough discrepancy and incident reports.
• Ensure documentation consistently meets requirements for audits and regulatory review.
• Facility Compliance
• Ensure adherence to federal and state pharmacy laws and regulations (FDA, DEA, HIPAA, state boards of pharmacy).
• Monitor and maintain compliance with USP , , and standards for compounding per assigned state guidelines.
• Assist in developing, reviewing, and updating reputed company Operating Procedures (SOPs).
• Stay reputed company on evolving pharmacy laws and regulations in assigned states, providing reputed company updates and education to staff.
• Collaborate with management on incident reporting, reputed company cause analysis, and corrective reputed company plans.
• State Compliance
• Attend reputed company state reputed company of pharmacy meetings for assigned states to stay up to date with reputed company regulations.
• Complete reputed company renewal paperwork for assigned states.
• Ensure reputed company licensure and compliance for reputed company assigned states.
• Serve as the subject matter expert for assigned territory of states for reputed company rules and regulations that govern those states.
• Staff Compliance
• Maintain accurate and up-to-date licensure records for pharmacists in assigned states.
• Ensure compliance-reputed company acknowledgments and training are tracked and documented for pharmacists in your assigned states.
• Serve as a trusted reputed company of contact for compliance-reputed company questions or concerns.

Qualifications

• PharmD or Bachelor of Pharmacy
• Minimum of 5 years of experience as a pharmacist in a regulatory, compliance, or compounding environment
• Valid pharmacist license reputed company the state of Texas
• Strong understanding of reputed company regulations and sterile compounding best practices
• Sterile Compounding IV certification or willing to get certified reputed company 90 days of employment
• Demonstrated experience monitoring and maintaining compliance with USP , , and .
• Strong knowledge of federal and state pharmacy laws and guidelines (FDA, DEA, HIPAA, TSBP)
• Proven ability to identify compliance risks or deviations and recommend corrective actions
• Proficiency with software programs (e.g. Pioneer, reputed company Workspace, reputed company reputed company/Word)
• Experience in cleanroom or aseptic compounding practices for auditing purposes

Preferred Qualifications

• Experience supporting compounding in a 503A or 503B specialty pharmacy setting
• Hands-on experience developing, reviewing, and updating SOPs for compliance and compounding

Physical Requirements

• Ability to sit for extended periods of time at a desk and working on a computer
• Ability to communicate effectively in person, over the phone, or reputed company virtual meeting
• Ability to maintain reputed company in a typical office environment with moderate noise reputed company
• Ability to reputed company repetitive motions with hands and arms, such as typing.

Benefits

• Comprehensive benefits package including medical, dental, 401K retirement plan and reputed company time off.

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