QA Inspector USA-OH Solon - Fountain/en-US/avantorJobs/job/USA-OH-Solon---Fountain/QA-Inspector_R-103955/apply Job Summary Ensures customer and regulatory requirements have been met by inspecting product and review of documentation throughout all aspects of the production process (e.g., manufacturing, filling, and labeling / assembly, etc.). Ensures compliance with all applicable standards and regulations (e.g., ISO 9001, ISO 13485, 21 CFR 820, 21 CFR 11, ISO 17025, and EXCiPACT), Good Manufacturing Practices (cGMPs), and Good Documentation Practices (GDPs). Provides Event and Complaint investigation support to other team members. MAJOR JOB DUTIES AND RESPONSIBILITIESnbsp; (List in order of importance) * Complies with company policies, procedures, work instructions, and training requirements focusing on customer service, production, and quality. * Keeps customer interests and regulatory requirements in mind, ensures customer needs are met by reviewing order requirements, customer documentation requirements, proper filling and assembly requirements, and, where needed, ensures other technicians understand and follow documented VWR Solon procedures and GMP requirements. * Ensures customer requirements are met. * Verifies adherence to policies, procedures, and work instructions. * Ensures documentation and physical product segregation and containment of non-conforming material identified during the production process. * Reviews production documentation for accuracy, completeness, and GDP compliance. * Assists in correcting order issues and ensures actions that are taken are appropriate. * Communicates issues / concerns to area owner and direct manager. * Ensures that the area is in a state of audit readiness at all times. * Performs inspection tasks by following established work instructions and procedures, by using required tools and methods and, when applicable, equipment, to determine acceptability of product, components, and documentation. * Performs pre-fill, in-process, and final inspections with the aid of documented work instructions and inspection information as required. * Stops production when a non-conformance (NCM) is observed and follows appropriate NCM procedures. * Documents non-conformances following applicable VWR Solon procedures and work instructions. * Documents and trends any quality production issues discovered during the course of inspection duties. * Ensures cleanliness of work areas during the inspection processes. * Utilizes problem solving tools such as 5M+E, 5 Whys, or other root cause analysis tools / methods to identify and permanently resolve issues. * Adheres to VWR Solons QMS and VWR Policies, where applicable. * Walks the floor to observe, train, and facilitate / support change. * Performs other duties as assigned. QUALIFICATIONS (Education/Training, Experience and Certifications) * High School completion or equivalent (GED) and a minimum of 3 years related experience and/or training in a regulated industry is required; OR * Bachelors degree is required * Experience in a Quality Assurance role within the medical device, biotech, or pharmaceutical industry is preferred KNOWLEDGE SKILLS AND ABILITIES (Those necessary to perform the job competently) * Must be able to balance multiple tasks and prioritize efficiently * Knowledge of ISO 9001, ISO 13485, 21 CFR 820, 21 CFR 11, ISO 17025, or EXCiPACT standard is preferred * Demonstrated experience or knowledge in conducting root cause analysis as it relates to nonconforming material investigations * Knowledge and experience utilizing Microsoft Outlook, Word, Excel, and Access, or equivalent software packages * Good communication skills ENVIRONMENTAL WORKING CONDITIONS amp; PHYSICAL EFFORT (Under Typical Positions) Works on the production floor with adequate lighting and ventilation with occasional elevated noise levels and a varying range of temperatures. Work assignments are diversified. Examples of past precedent are used to resolve work problems. New alternatives may be developed to resolve problems. A frequent volume of work and deadlines impose strain on routine basis.nbsp; Minimal physical effort is required; however, the position does require frequent walking, standing, bending, reaching, lifting or possibly carrying objects weighing up to 50 lbs. While performing the duties of this Job, the employee is occasionally exposed to fumes or airborne particles and toxic or caustic chemicals. DISCLAIMER: The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position. Avantor is proud to be an equal opportunity employer. EEO Statement nbsp; Avantor companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law. This site is governed solely by applicable U.S. laws and governmental regulations.nbsp; Use of this site constitutes your consent to application of such laws and regulations and ournbsp;Privacy Policy. Posted 22 Days AgoFull timeR-103955 Avantor® is a leading global provider of integrated, tailored solutions for the life sciences and advanced technology industries. Strengthened by the recent acquisition of VWR, the Company is a trusted partner to customers and suppliers from discovery to delivery. With operations in more than 30 countries and a diverse portfolio that includes more than four million products, Avantor enables customer success through innovation, cGMP manufacturing and comprehensive service offerings. Collectively, we set science in motion to create a better world. Learn more at www.avantorinc.com and www.settingscienceinmotion.com.