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Quality Compliance Specialist

2 months ago

Duluth, United States cyberThink Inc Full time

Job Description:

Our roles are not considered fully remote, so are officially considered hybrid. On average, outside of the training period, team members can expect to come on site 2 days a week or as requested by their leadership due to meetings, etc. Additionally, if team members do not have sufficient internet to work (or if they have an outage in their area), they would be expected to come on site to work since our offices are open.


Job Responsibilities:

  • Addresses and responds to all product inquiries, complaints, and suspected adverse events in a timely and appropriate manner and in compliance with US regulations (FDA, USDA, EPA), relevant GMPs, policies and procedures for the capture, maintenance and reporting of adverse events and product quality complaints.
  • Receive all product inquiries, complaints, and suspected adverse events that may arise by usage of or experience with products. Communication may be received from (but are not limited to) veterinarians, veterinary technicians and other veterinary support staff, consumers (pet owners), sales personnel, distributor sales representatives, or other personnel. The major form of communication is via telephone but may include email and hand delivered mail.
  • Provide information and support as requested in the following areas: proper product use, extra-label use, literature requests, adverse events, and unexpected response to treatment, perceived lack of efficacy, and product or packaging defects.
  • Maintain a high level of technical and clinical expertise related to products. Constantly upgrade technical expertise by reading journals and attending scientific seminars.
  • Document all communications within the Validated Database (PV Works) in accordance with SOPs and all compliance/GMP requirements and assess and implement appropriate responses and procedures.
  • Ensure timely and accurate communication and adherence to all SOPs, including escalating calls to Technical Services Veterinarians as needed.
  • Constantly upgrade technical expertise by reading journals and attending scientific seminars.
  • Support external and internal sales representatives as needed by providing technical support, answering client inquiries and attending and working at veterinary conferences.
  • Research pertinent topics and prepare reports as requested by the Manager. Participate in call analysis and report trends or issues involving product usage. Perform additional duties as assigned.
  • Performs all Company business in accordance with all regulations (e.g., EEO, FDA, etc.) and Company policy and procedures.
  • When violations are noted/observed they are to be immediately reported to management.
  • Demonstrates high ethical and professional standards with all business contacts in order to maintain excellent reputation within the animal health community and internally.
  • Must be able to understand and apply relevant GMPs and have an understanding of pharmacovigilance and complaint handling Compliance requirements.


Skills:

  • This position requires someone with a strong customer service background and a commitment to excellence. This position must understand the balance of providing customer service in a regulatory compliance environment to ensure strict adherence to all principles of good product stewardship in an effort to maximize product sales.
  • Must understand the balance of providing excellent customer service in a regulatory compliance environment.
  • Must possess a strong understanding of basic veterinary practice issues and procedures.
  • Attention to detail, quality focused and strong technical and problem-solving skills.
  • Excellent computer skills required (Microsoft Office Suite).
  • Excellent oral and written communication skills and an ability to operate effectively in a team environment.
  • Must have excellent organization and time management skills.
  • Ability to manage conflict and to balance business needs with user friendliness.
  • Ability to work independently, under pressure, demonstrating initiative and flexibility.
  • Animal Health or related industry and/or regulatory experience a plus


Education:

Associate Degree or higher (Life Sciences/Veterinary Technician) AND a minimum of 3 years experience working in a veterinary clinic (veterinary assistant and/or technician)


The hourly range for roles of this nature are $17 to $25/hr. Rates are heavily dependent on skills, experience, location and industry.