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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.
Job Responsibility:
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
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
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
Requirements:
Pharmacist License in good standing in the state of Kansas
2+ years of experience working in a regulated environment
Solid math and practical problem-solving skills with demonstrated use of sound judgement
Excellent attention to detail and documentation skills
Strong analytical, organizational, and communication abilities
Familiarity with quality management systems, deviation/CAPA systems, and audit processes
Ability to work cross-functionally in a fast-paced regulated environment
Ability to work with others in a positive and professional manner and to develop and maintain strong working relationships with co-workers and management
Ability to take initiative, including asking for and offering help when needed
performs work independently without being prompted
Strong attention to detail and focus on quality, accuracy, and accountability
What we offer:
Competitive salary
comprehensive benefits
performance package
ability to be part of an international leader in an expanding industry