• Pharmacy Compliance Analyst

    Job Locations US-IN-Charlestown
    ID
    2019-1690
    # of Openings
    1
    Category
    Other
  • Overview

    POSITION SUMMARY:

    The Pharmacy Compliance Analyst monitors and supports processes to ensure quality and compliance of the pharmacy dispensing operations and client program(s).

    • Responsible for quality checks for assuring products conform to established requirements and standards, including random audit and inspection activities (e., incoming inspections). Identification and recording of non-conformances through gathering relevant information and data.
    • Responsible for ensuring Good Documentation Practices (GDP), compliance with Standard Operating Procedures (SOP’s), Work Orders and Pharmacy Work Instructions, and assuring that Change Control is appropriately followed.

    Responsibilities

    KEY AREAS OF RESPONSIBILITY:

    Quality

    • Ensure quality control by participating in periodic audits of incoming product inspections, order fulfillment, and print processing activities for conformance to GDP, SOPs, Work Orders and Pharmacy Work Instructions.
    • Actively participate in the Knipper Quality Council and provide insight on pharmacy dispensing operations.
    • Monitor and provide data on cost of any pharmacy errors and omissions to the Knipper Quality Council.
    • Documentation, reporting, and analysis of Quality Events, rejected materials, concealed shortage/overages to Pharmacy Management, as applicable.
    •  Facilitate the investigative process involving the pharmacy dispensing operations to ensure Quality Investigations and CAPAs, including effectiveness checks are reviewed, approved, and resolved in a consistently compliant and timely manner.  Escalate any issues to Knipper Compliance and Pharmacy Management.
    • Collaborate with Pharmacy Management in resolving incidents using business communications, trending, root cause analysis, and corrective/preventive action activities to allow the business to improve product and process quality.

     Compliance

    • Communicate with Knipper Legal and Compliance teams to ensure that all HIPPA violations are timely addressed and resolved.
    • Work directly with the Knipper Training Team to ensure SOP’s and training documentation is managed through the Learning Management System (“LMS”)
    • Ensure KnippeRx Training Requirements Matrix is up-to-date with current positions and training requirements.  Submit to Knipper Training Team for management in the LMS.
    • Deliver procedure-based and Quality/Compliance training as required.
    • Ongoing assessment of procedures and policies to assure accuracy in documentation, data and activities performed (i.e., fraud, waste and abuse audits)
    • Review process change controls with Knipper QA Manager and Pharmacy Management; approve when appropriate.
    • Support client and third-party audits, including audit preparation, audit facilitation and audit remediation. 
    • Participate and support internal and vendor audits.  Review and approve CAPAs and effectiveness checks, associated with these audit types, in conjunction with Pharmacy Management.
    • Work with subject matter experts on technical subjects in a positive, collaborative manner to prepare controlled documents.
    • Review and/or revise pharmacy SOPS, Client Business Rules, Department Work Instructions, and other documents; escalates noncompliance to established timelines as appropriate.
    • Executes document controls and manages document changes.
    • Support process improvement activities for Pharmacy Operations, as needed.

     

    The above duties are meant to be representative of the position and not all-inclusive.

    Qualifications

    REQUIRED EDUCATION AND EXPERIENCE:

    • State of Indiana or PTCB Pharmacy Technician license is required.
    • Experience with drug reimbursement issues and claim adjudication process is preferred.
    • Experience with insurance benefits investigations; knowledge of U.S. Private and Government payers
    • Experience with HIPAA, cGMP and product quality complaints / adverse event reporting preferred
    • Ability to read, write, speak and understand the English language.

     Preferred

    • Associates Degree or higher
    • Two years QA or equivalent experience in regulated industry AA

     KNOWLEDGE, SKILLS & ABILITIES:

    • Excellent written and verbal communication skills.
    • Excellent analytical, problem solving and decision-making skills.
    • Ability to accept changing workflows and unexpected demands requiring flexibility.
    • Ability to work under pressure and appropriately prioritize responsibilities.
    • Ability to work independently with minimal supervision.
    • Ability to develop collaborative working relationships.
    • Working knowledge of Corrective Action Preventative Action processes
    • Ability to prepare and write investigational reports for management review.
    • Working knowledge of current Good Manufacturing Practices including Good Documentation Practices, and Good Distribution Practices.
    • Thorough understanding of the State of Indiana Board of Pharmacy Regulations
    • Working knowledge of FDA’s Quality Management System or equivalent.
    • Able to use Microsoft Excel and Word at the following levels:
    • Word – Basic Level: This level of skills is sufficient to perform daily word processing tasks, such as, producing routine letters, memorandums, and informal reports. A person with this level of skills is able to use basic formatting, editing, printing functions, and understands the document page setup.
    • Excel – Intermediate Level: This level of skills is required to work with multiple worksheets, filter data, use integrate functions, and manipulate databases. With this level of skills, a person understands the concepts of databases and is able to work with charts and to use the list management capabilities of Excel.
    • Visio – Intermediate Level: ability to confidently create and edit hierarchical diagrams, brainstorming grids, organizational charts, timelines.
    • Proficient in use of computers and ability to learn internal software programs.
    • Ability to use a calculator to perform basic math functions and understands the concept of same including: add, subtract, multiply and divide in all units of measure, using whole numbers, common fractions and decimals; compute ratio, rate and percent.
    • Able to control one's own time; seeks agreement on resource allocation taking into account all stake holders; demonstrates frugality by properly preparing and adhering to budgets; seeks ways to decrease cost and spend only on things that improve customer satisfaction; makes sure availability of resources necessary to safely and effectively conduct their job function.

     

    PHYSICAL REQUIREMENTS:

    • Location of job activities 100% inside
    • Occasional travel
    • Noise and/or vibrations exposure
    • Stand and sit for prolonged periods of time
    • Ability to lift and move up to 35 pounds

     

    Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

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