• Pharmacy Compliance Analyst

    Job Locations US-IN-Charlestown
    # of Openings
  • Overview


    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.




    • 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.


    • 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.



    • 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.


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


    • 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.



    • 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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