• REGULATORY & QUALITY ASSURANCE OFFICER

    Posted: 02/09/2020

     POST TITLE:                  REGULATORY & QUALITY ASSURANCE OFFICER

    Regulatory Department 

    Personal Attributes required for this Job:

    Communication skills, written and oral                     Thoroughness and Attention to Detail                     

    Interpersonal Awareness                                               Work Independently

    Results Driven                                                                    Team Player

    Time Management                                                          Analytical / Logical Thinking

    Adaptability                                                                       Concern for Standards

    Initiative                                                                               Flexibility                                                             

    Critical Information-Seeking                                        Efficiency Orientation

    Attention to Detail                                                            Problem solving                 

    Responsibilities:

    Essential:

    • Responsible for company’s Quality Assurance program, under guidance of Regulatory Manager, to ensure compliance of staff to company Standard Operating Procedures, Work Instructions, and forms.
    • Maintain knowledge of Good Distribution Practices in connection with Pharmaceutical Wholesale distribution as governed by the State Board of Pharmacy and the USFDA.
    • Assist in maintenance, upkeep, and updating of company Standard Operating Procedures, as needed, and to facilitate company compliance program, as directed by company senior management.
    • Assist in daily, weekly, monthly or annual internal audits as directed by the Regulatory Manager.
    • Perform monthly quality checks, to include: warehouse documentation, in-process inspections of product handling (Controlled Drug, HazMat, Cold Chain, etc.), product packing, and/or product documentation.
    • Monitor warehouse temperature and humidity records and maintain all documentation regarding calibration of temperature recorders,
    • Oversee product destruction and handle controlled drug product destruction.  Maintain all product destruction records.
    • Audit controlled drug job jackets to ensure that proper documentation is maintained per DEA regulations.
    • Assist Regulatory Manager with External audits by regulatory agencies, customers, suppliers, etc. as needed.
    • Any other duties assigned by your Manager

     Qualifications and Experience Needed:

    • Graduate, High School Diploma or GED. Some college preferred.
    • Minimum 2 years’ experience in regulatory, compliance, quality assurance, pharmaceuticals or some other related field.
    • Proficiency with Microsoft Office Suite
    • Adaptability and versatility in a dynamic environment
    • Ability to effectively work in a team environment while maintaining group morale and mutual respect
    • Positive attitude and strong work ethic

     

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