Details: “The Power to Look Deeper” Gen-Probe Incorporated is a global leader in the development, manufacture and marketing of molecular diagnostics products and services that are used to diagnose human diseases, screen donated human blood, ensure transplant compatibility, and aid biomedical research. Gen-Probe has nearly three decades of molecular diagnostics expertise, and received the 2004 National Medal of Technology, America's highest honor for technological innovation, for developing molecular assays and systems that help safeguard the blood supply. Headquartered in San Diego, CA, and with offices in Stamford, CT, Waukesha, WI, the United Kingdom, Germany and France, Gen-Probe employs over 1300 people around the world. “The Power to Shape Your Future” We are seeking a Quality Specialist II-III (Complaints) who will be responsible for responding to and managing all processes that support the Quality Complaint department including the processing of complaints, inquiries, action requests, CAPA and extensions. In addition, QA Complaints is responsible for performing a monthly peer review, tracking and trending all Complaints, monitoring timely completion and following up on Complaint investigations and Task owners. DESCRIPTION OF POSITION RESPONSIBILITIES: • Review information received on potential product complaints. • Evaluation complaint information for potential nonconformance or reportable, e.g., MDR, BDPR, Safety/Efficacy, etc. • Ensure proper documentation, investigation, and closure of each complaint in accordance to established company procedures. • Identify complaint trends. • Review and approve customer complaint responses. • Serves as QA interface to other departments, partners and Regulatory Bodies on complaints and investigations, etc. • Assists in developing quality systems & make recommendations to existing Quality systems. • Conducts complex technical troubleshooting activities & in-depth evaluations. • Develops, analyze, trends, maintains & reports department metrics. • Acts as a mentor to QA personnel. • Review and assess the appropriateness of document changes in accordance with internal procedures of a difficult and complex nature. TECHNICAL SKILLS, KNOWLEDGE AND ABILITIES: • Advanced knowledge of QC, Manufacturing & Inventory processes. • Working knowledge of QMS, QSR & ISO standards and requirements. • Advanced knowledge of Microsoft Word, Excel and related functions including the formulation of graphs. • Experience working in SAP strongly preferred. • Strong verbal and written communication skills are required. • Ability to prioritize, influence, and negotiate without direct line authority is required. EDUCATION & EXPERIENCE: • BA/BS and 2-5+ years related Quality experience. • Strong understanding and experience in Complaint and Nonconformance handling. • SAP experience strongly preferred. Gen-Probe offers a dynamic and innovative work environment along with excellent benefits that include company sponsored medical/dental/vision benefits, bonus potential, 401(k) with company match, paid vacation/sick time /holidays, assistance with continuing education, on-site fitness center and our own Waterfall Café.
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