Pharmacy Compliance Specialist, Auditing and Monitoring
Alto Pharmacy
Job Summary
Job Description
About the Role
As a Pharmacy Compliance Specialist, Auditing & Monitoring at Alto Pharmacy, you will play a pivotal role in ensuring the company's adherence to all relevant regulations and compliance standards. We are seeking someone who is a licensed pharmacist with a strong background in risk assessments and auditing, to join our dynamic team. This role plays a crucial part in ensuring our operations align with all relevant laws, regulations, and industry standards. You will work closely with the other members of the Compliance and Legal team and business partners in Quality, Care, and Fulfillment operations.
Accelerate Your Career as You
Play a key role in helping maintain the day to day compliance of our pharmacy operations.
Perform audits on operations and systems to determine the level of compliance to existing and newly instituted internal and external standards.
Communicate with individual departments to notify and address non-compliance issues.
Assist in communication, coordination, management and tracking of external audits and inspections.
Prepare documentation for submission to regulatory agencies in collaboration with other business stakeholders.
Investigate potential issues of non-compliance and assist with root cause analysis, corrective action and impact reports for internal departments.
Update policies and SOPs as required.
Specifically, you will:
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Conduct Risk Assessments
Evaluate and assess compliance risks associated with our business.
Identify potential areas of concern and develop strategies to mitigate risks effectively.
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Auditing and Monitoring
Plan and execute compliance audits and ongoing monitoring programs to ensure adherence to regulatory requirements.
Review pharmacy operations, documentation, and processes to identify and rectify compliance gaps.
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Track Compliance Inquiries and Investigate Complaints
Investigate and analyze complaints related to pharmacy operations, ensuring that they are addressed promptly and in accordance with regulatory guidelines.
Collaborate with stakeholder teams to gather data and resolve complaints efficiently and effectively.
Track, document and close complaints.
Create corrective action plans.
Documentation and Reporting
Maintain accurate records of compliance assessments, audit findings, and investigation outcomes.
Prepare comprehensive reports for senior leadership and regulatory agencies as required.
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Policy Development
Assist in the development and revision of compliance policies and procedures to reflect changing regulations and best practices in the pharmaceutical industry.
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Training and Education
Assist in providing training and guidance to pharmacy staff on compliance-related matters, ensuring a comprehensive understanding of regulatory requirements.
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Other Duties
Triage the compliance ticket queue.
Keep up-to-date with changes in pharmaceutical laws, regulations, and industry trends to proactively address emerging compliance issues.
Take on additional compliance-related tasks and projects as assigned by leadership.
Act as the primary point of contact and manage all responsibilities for regulatory audits.
A Bit About You
Minimum Qualifications:
Bachelor's or Doctorate degree in Pharmacy
Minimum of 8+ years of experience in pharmacy compliance, program management, investigations or auditing.
Strong knowledge of setting up and conducting risk assessments.
Excellent communication and interpersonal skills.
Detail-oriented with exceptional organizational and documentation skills.
Ability to work independently and as part of a team.
Strong analytical and problem-solving abilities.
Preferred Qualifications:
Certified in Healthcare Compliance (CHC) or similar certification or capable of acquiring within 18 months
Proficiency in compliance management software and Google Suite
Prior experience with regulatory oversight, quality assurance, policy writing, and participation in accreditation/inspection site visits
Prior experience with OIG and/or CMS requirements
Understanding of DEA CSA requirements
Understanding of OIG’s Seven Elements of a Compliance Program
Experience with Jira or Asana ticketing system
Proficiency in databases (SQL, MYSQL, Looker)
Salary and Benefits
Salary Range: $120,000 -$150,000
Commission Eligible: No
Equity Eligible: Yes
Travel: Yes - up to 25% of the time.
Employment Requirement: Applicants must be authorized to work for any employer in the U.S. At this time, Alto is unable to sponsor or take over sponsorship of an employment Visa.
Location Requirement: Employment at Alto is limited to individuals residing in the following states: Washington, California, Nevada, Colorado, Texas, and New York.
Benefits: Full-time: Medical, Dental, Vision, 401(k), Group Life, AD&D, Employer paid STD/LTD, generous PTO and parental leave.
Additional Physical Job Requirements
Read English, comprehend, and follow simple oral and written instructions. The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading. Assessing the accuracy, neatness and thoroughness of the work assigned.
Communicating with others to exchange information. Expressing or exchanging ideas by means of the spoken word; those activities where detailed or important spoken instructions must be conveyed to other workers accurately, loudly, or quickly.
Perceiving the nature of sounds at normal speaking levels with or without correction, and having the ability to receive detailed information through oral communication, and making fine discriminations in sound.
Frequent repeating motions required to operate a computer that may include the wrists, hands and/or fingers.
Sedentary work: Sitting most of the time, exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Walking & standing are required occasionally.
“Fully remote"
#LI-Remote
Additional Information
Alto Pharmacy is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, religion, sex, gender identity, sexual orientation, age, disability, veteran status, or any other legally protected basis. If you have a disability and require reasonable accommodation during any portion of the application or hiring process, please contact us at CandidateHelp@alto.com.
Alto Pharmacy considers qualified applicants with arrest or conviction records for employment and conducts background checks consistent with applicable law, including the California, Los Angeles County, San Francisco, and New York City Fair Chance laws. We are an E-Verify participating company.
To learn about Alto's privacy practices including compliance with applicable privacy laws, please click here.