Share Email Opening Title Product Complaints Analyst  About the Organization kaléo is a new type of pharmaceutical company, dedicated to building innovative solutions for serious and life-threatening medical conditions.   Description The Product Complaints Analyst is responsible for executing the product complaints process per corporate procedure and regulatory standards. The scope of responsibility encompasses executing the complaint processes to comply with corporate procedures and FDA regulations per CFR Part 820, 211, 210 and ISO13485 and other regulatory requirements as applicable. Serves as a Quality liaison between individuals and business units within or outside the organization regarding product complaint matters. Essential Functions/Principal Duties and Responsibilities Receive and initiate product complaint investigations using product complaints management software. Apply departmental procedures to assess product complaints’ impact on patient safety and product quality compliance. Notify the Complaint Manager regarding product complaints with potential regulatory notification. Interface and collaborate with various departments, including Quality Assurance, Regulatory, Development, Safety/Pharmacovigilance and vendors and contractors on product complaint issues. Conduct follow-up with reporters for additional information necessary to complete a detailed investigation. Provide responses to product complaint reporters. Support product complaint investigations. Data entry and analysis to support tracking and trending of complaints. Data entry and analysis to support electronic Quality Management System. Perform other duties as assigned.   Open Date 3/15/2019   Position Requirements Educational or Certification Requirements Bachelor’s degree in engineering or life science. 0-3 years of experience in Quality Assurance or a GMP-related field within the medical device or pharmaceutical industry. Competency Requirements Exceptional attention to detail and good organizational skills. Excellent communication skills. Skilled in technical writing. Ability to work independently and able to schedule work with limited supervision to meet deadlines. Ability to develop solid working relationships with colleagues, partners, and contractors. Other Preferred Experience or Qualifications Knowledge of Current Good Manufacturing Practice regulations and other regulatory requirements governing combination drugs and device products. Knowledge of US Food and Drug Administration cGMP requirements pertaining to drugs and device product complaints reporting and investigations.   Exempt/Non-Exempt Non-Exempt   Full-Time/Part-Time Full-Time   EOE Statement We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, national origin, disability status, protected veteran status or any other characteristic protected by law.   Location Corporate   This position is currently not accepting applications. To search for an open position, please go to http://KaleoPharma.appone.com WE ALSO RECOMMEND Other Jobs Within Same Category -- None found -- Other Jobs Within 60 Miles -- None found -- Follow us See who works here:

 

AppOne.comTM   copyright©1999-2021 HR Services, Inc. Click here for technical assistance.