Job Description
Target PR Range: 35-45/hr
*Depending on exp
Job Description: Conducting complaint investigations and associated tasks to ensure complaint investigations are thorough, investigation conclusions are appropriate, appropriate procedures are followed, and complaint investigations are conducted and closed in a timely manner.Reviewing & identifying the root causes of complaints and works with the applicable operational departments such as: Product Development, Manufacturing Engineering, and Quality Engineering to ensure an appropriate resolution.Responding directly to customers to investigate and resolve complaints, when necessary.Assisting in the development of training materials and process enhancements related to complaints management.Facilitating complaint sample returns (from consumer, pharmacy, healthcare provider or distributor) for inspection/investigation, as needed.Participate in quality management system meetings regarding complaints and complaint handling.Performing duties in accordance with the Company's Quality Systems and with standard operating procedures (SOPs) that are consistent with regulatory requirements and industry standards.Providing input to support the continual improvement of complaint handling processes.Performing other related duties as assigned. EDUCATIONAL REQUIREMENTS (degree, license, certification): Bachelor's Degree in the Sciences or related field is required or equivalent work experience YEARS OF EXPERIENCE: 1 or more years in product complaint investigation experience. OTHER SKILLS AND ABILITIES: Strong computer skills. Proficiency with Microsoft Office business software and use of information databasesKnowledge of GMP, ISO, QSR and other applicable international regulations, standards, Directives and GuidanceProven ability to communicate effectively; orally and writtenAbility to manage multiple tasks and projectsAble to work independently, as well as in a cross-functional team environmentCustomer service oriented attitude and ability to exercise sound business judgmentAbility to maintain confidentiality and discretion in business relationshipsAble to define problems, organize and collect data, establish facts, and draw valid conclusionsBackground in manufacturing processes for sterile pharmaceutical products and drug-device combination products related to development and commercial programs a plusTravel between sites as needed
