Regulatory Compliance Auditor, Internal Audit - Bethlehem, PA, United States - Central Admixture Pharmacy Services, Inc.

    Central Admixture Pharmacy Services, Inc.
    Central Admixture Pharmacy Services, Inc. Bethlehem, PA, United States

    1 month ago

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    Full time
    Description
    Central Admixture Pharmacy Services, Inc.
    Reg Compliance Auditor CAPS


    Type:
    Regular Full-Time

    # Category:
    Quality Compliance

    CAPS, the nation's largest network of outsourcing admixture pharmacies, has been delivering high-quality, same-day, admixture services and solutions to hospitals and outpatient facilities for more than 28 years.

    Along with the nation's largest 503A sterile injectable outsourcing network, CAPS offers industry-leading batch compounding on a national scale through three 503B registered outsourcing facilities.

    This position responsible to assess, assure, and maintain State and Federal compliance for CAPS pharmacies / facilities.
    Perform internal audits of CAPS pharmacies / facilities

    • Perform quality control documentations/systems
    • Support with planning and scheduling of internal and supplier audits
    • Perform external supply audits as necessary
    • Support Board of Pharmacy (BOP), FDA, customer, supplier, and other regulatory audits
    • Provide compliance support to operations
    • Support customer inquiries and complaint responses
    • Support the Supplier Quality Management initiatives
    Good working knowledge of other Pharmaceutical (21 CFR 210 & 211, and 503B) Quality System Regulations

    • Must be proficient with Microsoft office applications
    • Ability to use scientific principles/process knowledge to make critical compliance decisions
    • Interact with regulatory agencies effectively
    • Ability to provide training and guidance
    • The targeted range for this role takes into account a range of factors that are considered when making compensation and hiring decisions; experience and training; Target Based Range
    $Qualifications - Experience/Training/Education/Etc
    BS degree in technical or scientific discipline , or equivalent experience
    * - 5 years experience in Pharmaceutical/medical device industry, 2 of which are in compliance or equivalent experience

    • Up to 25% travel required
    • May require passport
    * cGMP training/experience required.

    • Aseptic processing training/experience required.
    Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
    Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Braun offers an excellent benefits package, which includes healthcare, a 401(k) plan, and tuition reimbursement. Equal Opportunity Employer Veterans/Disabled

    All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.