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Investigative Writer

Lornamead

$23 - $25 / hour
Apply before: August 31, 2024
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  • Date posted
    April 30, 2024
  • Location
    Onsite
  • Salary
    $23 - $25 / hour
  • Apply before
    August 31, 2024
  • Career Level
    Any

Job Description

Lornamead is currently seeking an Investigative Writer to join our team! Lornamead, Inc. manufactures and supplies, hair care, skin care, oral care, and bath products in America. The company offers toothpastes, teeth whitening products and oral analgesics for drug chains, and national food retailers. The company is headquartered in New York, with a manufacturing facility in Tonawanda, New York. Lornamead is a US division of Meiyume who is a global beauty company across major cities across the globe. YOUR CHALLENGE: Reporting directly to the Director of Quality and Regulatory Compliance, he/she will be responsible for the performance and authoring of investigations related to customer/consumer complaints and deviations identified during routine operations in a cGMP Facility. Essential Functions: – Timely and accurate execution of deviation investigations in accordance with internal policies, procedures and in compliance with cGMP requirements. – Collation of information from applicable sources including but not limited to personnel interviews, batch production reviews, analytical and manufacturing data analysis and trending, etc. – Use of effective analysis tools (Five Why’s, Fishbone, etc.) to identify root cause(s), perform risk/impact assessment(s) and identify/implement Corrective and Preventive Actions (CAPA). – Monitoring and analysis of investigation trends – Facilitation of effective communication and collaboration between Production and Quality Teams – Investigation of product quality complaints for internal and third party manufactured products in a timely manner. – Performs impact assessments and reviews completed investigations by third party manufacturers. – Maintains the historical and current files for all complaint intake related documents. – Monitoring and trending of complaints for Quality Metrics – Performance of other duties assigned by Quality Management to ensure uniform quality assurance throughout the entire company. Education and Experience: – 3-5 years of work experience in field subject to current Good Manufacturing Practices – Experience in leading and writing event investigations, including root cause analysis and CAPA – Experience in writing cGMP quality event investigations – Additional certifications such as CQE, CQA, desirable. Knowledge, Skills and Abilities: – Strong knowledge of cGMPs (FDA cGMP, CFR Parts 210 and 211, USP Chapters/Monographs) and experience in GMP processes and pharmaceutical document review to understand and guide process improvements. – Understanding of quality systems and root cause analysis/risk assessments. – Professional appearance, with excellent interpersonal communication skills including presentation skills, and multitasking ability – Strong computer skills, knowledgeable with standard Microsoft Office suite, email, document scanning, and strong Excel and Word experience – Self-motivated and organized with minimum supervision. – Ability to independently utilize critical thinking skills.