Sign up to access all features of our service.
  • Job search
  • Favorites
  • Create a CV
    New
  • Salaries
  • Subscriptions

Quality & Compliance Specialist

AmeriPharma

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.

AmeriPharma
Vacancy posted 1 day ago
Similar jobs that could be interesting for youBased on the Quality & Compliance Specialist in Orange, CA vacancy
  • $42.19 - $56.05 per hour

     ...Avid Bioservices is seeking a Sr. Specialist, Quality Systems in Tustin, CA to provide technical reviews of Quality Management System discrepancy...  ...authoring and editing critical quality documents, ensuring compliance with regulations. Candidates require a B.A. or B.S. in life... 
    Suggested
    Hourly pay

    Avid Bioservices

    Tustin, CA
    3 days ago
  •  ...SIFCO Industries, Inc in Orange, CA is seeking a Quality Compliance & Document Control Coordinator to manage all controlled documents and ensure compliance with AS9100D and NADCAP standards. This role is crucial in maintaining documentation accuracy and facilitating audits... 
    Suggested

    SIFCO

    Orange, CA
    3 days ago
  •  ...people who need them today. We are seeking an experienced Quality Improvement Specialist to support our Orange County Cancer Specialty Hospital....  ...in clinical nursing and/or quality, risk and regulatory compliance. Current Registered Nurse license in California Specialty... 
    Suggested
    Work experience placement

    Cancer Treatment Centers of America

    Irvine, CA
    4 days ago
  • $70k - $80k

     ...A leading healthcare company is seeking a Quality Systems Specialist in Irvine, CA. The role involves managing the North American Quality Management System, ensuring compliance with regulatory requirements, and participating in continuous improvement initiatives. Candidates... 
    Suggested

    Fisher & Paykel Healthcare, Inc.

    Irvine, CA
    4 days ago
  • $96k - $118k

     ...NCSL International is seeking a Quality Specialist II based in Irvine, California, to oversee the Quality System, ensuring compliance with regulatory standards and internal procedures. The role involves reviewing documentation and processes to support product quality and... 
    Suggested

    NCSL International

    Irvine, CA
    3 days ago
  •  ...Microchip Technology Inc. is seeking a Quality Analyst in Garden Grove, California, to support and enhance quality systems within the...  ...'ll be essential in maintaining quality records and ensuring compliance, while working closely with various teams to promote effective... 

    Microchip Technology

    Garden Grove, CA
    4 days ago
  • $25.2 - $30 per hour

     ...Quality Compliance & Document Control Coordinator Orange - QAF - Orange, CA 92867 Overview Salary Range $25.20 - $30.00 Hourly Position Type Full Time Job Shift 1st Shift Description The Quality Compliance & Document Control Coordinator is responsible for... 
    Hourly pay
    Full time
    Contract work
    Temporary work
    Work at office
    Flexible hours
    Shift work
    Day shift

    SIFCO

    Orange, CA
    4 days ago
  • JobRx, Inc. is seeking a QA Specialist in Costa Mesa, California, responsible for reviewing batch production records and ensuring compliance with FDA, EMA, and internal QMS requirements....  ...apply knowledge of cGMP regulations and quality systems to identify discrepancies and... 

    JobRx, Inc.

    Costa Mesa, CA
    2 days ago
  •  ...TAD PGS, Inc. is seeking a Quality Assurance Administrator for their Irvine, CA location. This role involves supporting the Quality...  ...organization by maintaining accurate quality records, ensuring compliance with aerospace quality requirements, and preparing essential documentation... 
    Contract work
    Work at office

    Tad PGS

    Irvine, CA
    1 day ago
  •  ...environment for employees. As we continue to grow, maintaining consistent service quality, compliance, and employee development is critical. The Field Quality Assurance & Training Specialist plays a key role in supporting these efforts across all branch operations. This... 
    Full time
    Local area

    Air Comfort, Inc

    Anaheim, CA
    5 days ago
  •  ...Astiva Health is looking for a Quality Improvement Coordinator in Orange, California. This role involves coordinating quality improvement...  ...HEDIS measures and collaborating with stakeholders to ensure compliance and improve service delivery. The ideal candidate will have 3+... 

    Astiva Health

    Orange, CA
    17 hours ago
  •  ...Quality Assurance Auditor Pharmaceutical client in Irvine, CA is searching for a Quality Assurance Auditor to join the Quality Compliance team in Irvine, CA! In this role, you will: Lead internal audits for the site's compliance to GMP regulations, collaborate with... 

    Aequor Inc

    Irvine, CA
    1 day ago
  •  ...Description: Position Summary: The ASC Accreditation & Compliance Specialist is Acuity Eye Group's centralized subject matter expert for...  ...biological indicator results, medication management logs, and quality indicators on a structured monitoring schedule Conduct... 
    Work at office
    Immediate start

    Acuity Eye Group

    Orange, CA
    1 day ago
  • $35 - $43 per hour

     ...Job Summary The Supplier Quality Analyst is responsible for ensuring that suppliers of materials, components, and services used in...  ...quality, regulatory, and risk requirements. This role supports compliance with FDA Quality System Regulation (21CFR820), ISO13485 through... 

    Planet Pharma Group

    Irvine, CA
    6 hours ago
  •  ...Job Summary The  Regulatory Affairs Specialist (FDA, DEA)will ensure BaRupOn's pharmacy, manufacturing, and healthcare...  ...responses to 483s or warning letters Coordinate with Quality Assurance on SOP compliance, change controls, and deviation reports Serve as... 

    Barupon LLC

    Irvine, CA
    1 day ago
  •  ...Health, visit Your Role on the Team Position Summary: Involves the review and evaluation of healthcare regulatory compliance controls and programs. Develops regulatory policies and systems from a strategic perspective; keeps abreast of regulatory issues,... 
    Full time
    Monday to Friday

    University Of California Irvine

    Placentia, CA
    17 hours ago
  •  ...MUST HAVE COMPLIANCE EXPERIENCE WITH TAX CREDIT, HUD, and FAIR HOUSING! Please visit...  ...Services industry who has provided quality service to customers since 1972! We consider...  ...for various developments, the Compliance Specialist is responsible for monitoring,... 
    Local area

    Barker Management

    Anaheim, CA
    1 day ago
  • $42.41 - $63.62 per hour

     ...oriented people to join our exceptional team. Senior Lending Compliance Specialist (Senior Compliance Specialist) The pay range for this...  ...as a resource for technical guidance to all Compliance and Quality Assurance team members. Conducts presentations and training... 
    Temporary work
    Work at office

    SchoolsFirst Federal Credit Union

    Tustin, CA
    17 hours ago
  •  ...has an open position for a Senior Regulatory Affairs Specialist based in the Irvine, CA location....  ...Pre-Market: Reviews documents for regulatory compliance necessary for the acceptability of quality documentation for submission filing. Develop pre... 

    LGM Pharma

    Irvine, CA
    2 days ago
  • $80k - $100k

     ...The Regulatory Affairs Specialist is responsible for investigating and supporting regulatory...  ...Affairs product files to support compliance with regulatory requirements. Keeps...  ...Licensing, Health Canada etc. Support Quality Systems Projects as required. Adhere... 
    Full time
    Work at office
    Local area
    Monday to Friday
    Afternoon shift

    Nihon Kohden

    Irvine, CA
    4 days ago
  • $30 - $45 per hour

     ...Competitive Compensation Paid Time Off Career Growth Opportunities Job Summary We are seeking a skilled Labor Compliance Coordinator to join our team. In this role, your aim is to ensure employees are compensated accurately and promptly. Your responsibilities... 
    Hourly pay

    JLM Strategic Talent Partners

    Anaheim, CA
    4 days ago
  •  ...Irvine is seeking a candidate to oversee healthcare regulatory compliance at UCI Health. The role involves evaluating compliance...  ...insurance and retirement plans. Join UCI Health in providing quality care to a diverse population in Orange County. #J-18808-Ljbffr... 

    UC Irvine

    Placentia, CA
    17 hours ago
  •  ...Position Summary Involves the review and evaluation of healthcare regulatory compliance controls and programs. Develops regulatory policies and systems from a strategic perspective; keeps abreast of regulatory issues, plans for changes and/or integration as new healthcare... 
    Full time
    Monday to Friday

    University Of California Irvine

    Placentia, CA
    4 days ago
  •  ...technology. We are committed to delivering high-quality diagnostic tools that improve patient...  ...the highest standards of regulatory compliance and quality excellence. Position Summary...  ...-oriented Senior Quality Assurance Specialist to support and enhance our Quality Management... 
    Local area
    Remote work

    Seegene

    Irvine, CA
    3 days ago
  • $72k - $80k

     ...Role ClearPath Medical is a contract manufacturer specializing in custom medical cable assemblies. We're looking for a Quality & Training Specialist to own product and process quality on our production floor while developing the training programs that keep our team skilled... 
    Full time
    Contract work
    All shifts

    ClearPath Medical LLC

    Tustin, CA
    6 hours ago
  • $85k - $110k

     ...is seeking a Senior Regulatory Affairs Specialist for a direct hire opportunity with one of...  ...development to commercialization and post-market compliance. Salary Range: $85,000 – $110,000...  ...of documentation for regulatory and quality compliance to ensure acceptance for... 
    Temporary work
    Local area

    Kelly Services

    Irvine, CA
    21 days ago
  •  ...and supporting documentation for completeness, accuracy, and compliance * Support product release activities and ensure adherence to...  ..., and ALCOA+ principles * Review deviations impacting batch quality and assist with CAPA activities * Maintain quality documentation... 

    Hydrogen Group

    Costa Mesa, CA
    3 days ago
  • $96k - $118k

     ...and lowering costs. To learn more about B. Braun Medical, visit Position Summary The Quality Specialist II provides oversight of the Quality System to ensure compliance with regulatory standards and internal procedures. This role supports product quality and safety... 
    Work at office

    B. Braun US Pharmaceutical Manufacturing LLC

    Irvine, CA
    11 days ago
  • $80k - $90k

     ...Kimley-Horn is looking for a Human Resources (HR) Compliance Specialist to join our Orange, California office. You will be responsible for ensuring compliance with various employment regulations and managing HR initiatives. The ideal candidate has 5+ years of HR compliance... 
    Work at office

    Kimley-Horn

    Orange, CA
    4 days ago
  • $28 - $38 per hour

     ...A staffing agency in California is seeking a candidate with a strong background in construction or transportation for compliance support on major projects. Responsibilities include tracking payroll, evaluating contracts, and ensuring compliance with labor laws. The role... 
    Hourly pay

    JLM Strategic Talent Partners

    Anaheim, CA
    3 days ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to Quality & Compliance Specialist. Be the first to apply!