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Quality & Compliance Specialist

Quality & Compliance Specialist

AmeriPharmaOrange, CA, US
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Quality & Compliance Specialist

AmeriPharma is a rapidly growing healthcare company where you will have the opportunity to contribute to our joint success on a daily basis. We value new ideas, creativity, and productivity. We like people who are passionate about their roles and people who like to grow and change as the company evolves.

The Quality & Compliance Specialist is responsible for supporting and monitoring organizational compliance and quality assurance efforts, including but not limited to Pharmacy and Infusion Operations. This role involves conducting compliance investigations, analyzing legal and regulatory risks, supporting accreditation and licensure activities, and contributing to the development and implementation of policies and training that ensure alignment with applicable healthcare standards and regulations.

Location : On-Site, Orange, CA.

Hours : Monday-Friday, 9 : 00 AM - 5 : 30 PM.

Duties and Responsibilities :

  • Organizes and helps manage compliance, quality, and legal matters.
  • Coordinates the collection, review, management, and production of documents.
  • Responds to discovery requests.
  • Conducts legal and compliance research and investigations.
  • Assists with general preparation, and filing and handles office administrative tasks and issues.
  • Clearly explains laws, rules, and regulations, as well as what constitutes a violation.
  • Exhausts options, such as seeking voluntary compliance, before resorting to enforcement action.
  • Recognizes situations that warrant assertive action and immediate followup.
  • Makes critical decisions based on data analysis and a strong understanding of the legal and regulatory requirements applicable to pharmacy industry.
  • Accommodates and adapts to change as environmental, organizational, workload, task, direction, and other conditions change in a constructive and positive manner.
  • Demonstrates ability to work with a diverse group of people in a manner that enables them to reach their full potential, in pursuit of organizational objectives.
  • Investigate, gathers facts, documents and responds to compliance and privacy related matters as assigned with including interviews with clinical and non-clinical staff.
  • Trains staff on compliance and privacy policies and procedures.
  • Provides recommendations for corrective action plans for compliance and privacy incidents.
  • Performs periodic reminders of staff responsibilities to following compliant work practices.
  • Actively participates in rounding on an ongoing basis and communicates trends and areas for improvements.
  • Provides input in the development of the annual compliance work plan.
  • Assists Department leader to develop, implement, and monitor key compliance functions and risk areas in accordance with OIG guidance for compliance program.
  • Presents status reports of assigned tasks to Compliance Manager on a regular basis.
  • Coordinates and completes applications for licensure, certification, and accreditation.
  • Collect, analyze, and assess quality data measures in accordance with all applicable accreditation standards.
  • Reviews contracts and laws and motions.
  • Conducts effective and thorough research-based memorandums.
  • Assists the compliance manager in monitoring the effectiveness of company compliance program and helps in compliance related projects.
  • Helps the compliance manager to coordinate with other organizational functions such as human resources, legal affairs, and others, educational and training programs focusing on the elements of the compliance program to ensure that the staff is knowledgeable of and comply with applicable federal, state, and industry standards.
  • Documents meeting minutes related to the Quality and Compliance department.
  • Monitors Pharmacy Licenses and Accreditation Awards.

Required Qualifications :

  • Good interpersonal skills.
  • Excellent verbal and written communication skills.
  • Ability to work independently, meet deadlines, and be flexible.
  • Good organizational skills and detail-oriented.
  • Knowledge of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), CA State Board of Pharmacy rules, CMS rules, CA labor laws and rules, DEA rules, FDA, and OSHA regulations.
  • Ability to perform tasks accurately and efficiently when inputting information.
  • Basic math and analytical skills.
  • Intermediate typing / keyboarding skills.
  • Ability to read, write, speak, and understand English.
  • Education and Experience Requirements :

  • Bachelor's Degree required.
  • Minimum of 2 years experience in regulatory compliance.
  • Preferred Qualifications :

  • Experience working in healthcare setting, preferred.
  • Majoring in Healthcare Administration, Business Administration, or Legal Studies preferred.
  • Healthcare Corporate Compliance preferred.
  • Certified in Healthcare Compliance (CHC) preferred.
  • Subject-matter expertise in the pharmaceutical industry preferred.
  • AmeriPharma's Mission Statement :

    Our goal is to achieve superior clinical and economic outcomes while maintaining the utmost compassion and care for our patients. It is our joint and individual responsibility daily to demonstrate to outpatients, prescribers, colleagues, and others that We Care!

    Physical Requirements :

    The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is continuously required to sit and talk or hear. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel objects, tools, or controls; reach with hands and arms; and stoop, kneel, crouch or crawl. The employee must regularly lift and / or move up to 20 pounds and occasionally lift / or move up to 30 pounds. Specific vision abilities required by this job include close vision, peripheral vision, depth perception and the ability to adjust focus.

    EEO Statement :

    The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all responsibilities, duties and skills required. The duties and responsibilities of this position are subject to change and other duties may be assigned or removed at any time. AmeriPharma values diversity in its workforce and is proud to be an AAP / EEO employer. All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, age, protected veteran status, or based on disability or any other legally protected class.

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    Quality Compliance Specialist • Orange, CA, US

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