Compliance Pharmacist

This job was posted by https://www.kansasworks.com : For more

information, please see: https://www.kansasworks.com/jobs/13441313

As a Compliance Pharmacist, you will be a responsible, servant leader

who is methodical and goal-oriented to ensure that all compounding

operations are performed in compliance with FDA regulations. One who

operates according to Standard Operating Procedures within the quality

system, all applicable state and federal pharmacy laws and the

requirements of cGMP. Ensuring DEA and cGMP compliance by continuous

review and auditing of facility operations. This role bridges the

pharmacy operations and quality assurance to maintain regulatory

compliance, oversee documentation practices and support audits,

investigations and regulatory inspections.

Key Responsibilities

Operational

• Hand hygiene/Garbing
• Weighing of ingredients, pH adjustments
• Proper cleaning
• Formulation, filling, visual inspection, labeling process assessment
• Training collaborations
• Evaluate current procedures/processes to identify areas of potential
  
  

risk within the production operations and help develop strategies to

mitigate these risks.

• Conduct training sessions for employees on compliance-related
  
  

issues/topics

• Create and update SOPs to maintain compliance with regulatory
  
  

standards

• Responsible for leading initiatives and tracking scrap reduction
  
  

within the facility

\

Daily Responsibilities

• Monitor day-to-day compounding operations to ensure compliance with
  
  

FDA 503B requirements and cGMP regulations.

• Perform regular internal audits and gap assessments of operations to
  
  

identify potential compliance issues and assist with implementation

of corrective actions as needed to maintain regulatory and cGMP

compliance

Overall

• Assist in developing, implementing, and maintaining training
  
  

protocols that align with established media fills, smoke studies,

and regulatory expectations.

• Evaluate current procedures/processes to identify areas of
  
  

improvement, streamline operations and enhance productivity

• Review batch records, deviations, CAPAs, EM data for compliance
  
  

risks

• Stay current on regulatory changes and other 483s/warning letters
  
  

(FDA guidance, USP chapters, etc)

• Participate in regulatory audits as needed
  
  

## Basic Qualifications

• [Pharmacist License in good standing in the state of
  
  

Kansas]{contrast="auto"}

• [2 years of experience working in a regulated
  
  

environment]{contrast="auto"}

• [Solid math and practical problem-solving skills with demonstrated
  
  

use of sound judgement.]{contrast="auto"}

• [Excellent attention to detail and documentation
  
  

skills.]{contrast="auto"}

• [Strong analytical, organizational, and communication
  
  

abilities.]{contrast="auto"}

• [Familiarity with quality management systems, deviation/CAPA
  
  

systems, and audit processes.]{contrast="auto"}

• [Ability to work cross-functionally in a fast-paced regulated
  
  

environment.]{contrast="auto"}

• [Ability to work with others in a positive and professional manner
  
  

and to develop and maintain strong working relationships with

co-workers and management.]{contrast="none"}

• [Ability to take initiative, including asking for and offering help
  
  

when needed; performs work independently without being

prompted.]{contrast="none"}

• [Strong attention to detail and focus on quality, accuracy, and
  
  

accountability.]{contrast="none"}