With over a decade of experience in post-market quality assurance for leading pharmaceutical companies, my core competencies lie in complaint handling, corrective and preventive action (CAPA), and clinical data management. At AbbVie, my mission was to ensure the highest standards of product quality and safety, aligning with the company's dedication to patient care. My work contributed to fostering a culture of excellence and compliance within the organization.In my role at AbbVie, I meticulously managed commercial and clinical complaints, enhancing regulatory compliance through rigorous analysis and accurate reportability. This role required me to be adept at navigating complex regulatory environments, evidenced by my submission of reports via the FDA's MedWatch Form 3500A. My commitment to quality was paramount as I processed and released Engineering Change Orders, ensuring continual improvement and adherence to stringent industry standards.
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Post Market Quality Assurance AnalystAbbvie Sep 2013 - Dec 2023● Responsible for the completion of all tasks associated with management of complaint handling including reviewing, coding, investigating, resolving, and closure of commercial and clinical complaint files of Natrelle® breast implants and the JUVÉDERM® family of dermal fillers as per 21 CFR Part 803, 820, and 211● Analyzed incoming documents and medical information for complaint data and reportability from 1,000+ intakes quarterly, ensuring accurate reportability and enhancing regulatory compliance● Submitted applicable reports on the FDA's MedWatch Form 3500A● Processed and released Engineering Change Orders across multiple document types● Certified AbbVie trainer responsible for training new employees and updating training materials● Provided customer service and performed further investigation with internal and external customers to obtain pertinent information and device return -
InstructorTexas Laser And Aesthetics Training Academy Jul 2018 - Dec 2022● Instructed and supervised a team of laser apprentice students as they performed 100 body sight treatments required for laser hair removal technician licensing● Supervised and provided laser hair removal, tattoo removal, intense pulsed light (IPL), micro needling, CoolSculpting®, and ablative skin resurfacing treatments to clients of all skin types● Conducted treatment consultations and designed individual treatment plans to best achieve client goals, identify contraindications, and up/cross sell services and products for optimal results● Performed receptionist duties including welcoming clients, checking them in and out, answering phone calls, selling skin care products, and scheduling appointments
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Multichannel Sales AssociateBest Buy Jan 2015 - Dec 2018● Provided fast and friendly over-the-phone customer support for three Best Buy locations from one centralized location● Engaged customers using soft skills while solving various issues and providing end to end solutions● Promptly responded to customer requests for information and assistance and addressed customer concerns● Placed product orders over the phone and generated a percentage of the store's overall sales
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Merchandise AssociateCirque Du Soleil - Kooza Aug 2015 - Oct 2015● Sold, restocked, transported, and organized event merchandise for the VIP lounge● Maintained accurate inventory counts and assisted with merchandise placement● Greeted and assisted VIP guests with various requests throughout the show
Jack H. Education Details
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Western Illinois UniversityMarketing, Music Business Minor
Frequently Asked Questions about Jack H.
What is Jack H.'s role at the current company?
Jack H.'s current role is Post Market Quality Assurance | Complaint Handling | Regulatory Compliance | Medical Device Complaints | CAPA | Root Cause Analysis | Regulatory Submissions | Training | Professional Laser Technician | Esthetician.
What schools did Jack H. attend?
Jack H. attended Western Illinois University.
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