Company DescriptionSPECTRAFORCE TECHNOLOGIES INC (www.spectraforce.com) offers a powerful suite of IT and Consulting services allowing companies to embrace the challenges of meeting and exceeding the company's IT needs with an aggressive Total Cost of Ownership. We enable companies to focus on their core competencies, while we handle the integral details of building IT solution guaranteeing quality delivery with significant cost savings. We offer a competitive edge through our Staff Augmentation Services (PrimuSourcing) and Projects Outsourcing Services, which are powered by our Global Delivery Model with teams based onsite in the USJob DescriptionJob Description:In compliance with current good manufacturing practices, the Product Complaint Associate is responsible for supporting the complaint handling Quality system through the timely assessment, processing, distribution of information, and communication of alleged product quality defects for all drug products within the scope of the Global Product Quality Complaints (GPQC) Group. QualificationsEssential Functions:• Triage all incoming reports to immediately identify the following:• Product and medical device complaints• Complaints that require expedited processing due to potential compliance issues.• Responsible for recording and processing quality complaint information received into the global complaint database. This includes:• Entering new complaint records• Determine when a complaint should be investigated or recorded for trending purposes only.• Determine when a complaint sample should be retrieved for evaluation.• Issue response letters to complainants regarding product complaints received.• Contact reporters either by email or phone, as necessary, to gather additional complaint information.• Complete daily workload while maintaining consistent, right first time quality work and compliance with established procedures and timelines. This may require the Associate to triage and process a minimum number of reports on a daily basis as specified by the US Complaints Operations managers. Additional InformationAll your inforSkills:• Understanding of Code of Federal Regulation (CFR) good manufacturing practices for finishedpharmaceuticals with emphasis on complaint handling requirements.• Understanding/knowledge of over-the-counter, pharmaceutical, and medical device products, packaging, and labeling with emphasis on complaint handling requirements. *Experience with sterile and medical device product within a healthcare setting and/or manufacturing and packaging is a plus.• Experience with triage activities that include but are not limited to identifying product and medical device complaints and the necessary decision-making skills that align with procedures.• Experience with computer systems including database, spreadsheet and word processingapplications.• Excellent oral and written communication skills that align with providing optimal levels of customer service, providing accurate product information, and compliance with good manufacturing practices and procedures.• Possess organizational skills/flexibility/teamwork in order to effectively prioritize daily workload and consistent maintain compliance with procedure timelines.• Must have ability to address obstacles with energy and determination and exhibit commitment tochange and passion for best interests.mation will be kept confidential according to EEO guidelines.