Quality Assurance Auditor

Quality Assurance Auditor - Scientific

Every day, Kelly Scientific Resources helps scientific professionals with their careers. Kelly is currently staffing for a Quality Assurance Auditor . This position is taking place at a well-known Healthcare company in Roundlake, Illinois. By working with Kelly in this role, you would be eligible for: - A competitive hourly pay rate with weekly checks - Access to newly expanded Medical Plan options - Online continuing education via the Kelly Learning Center - Several employee discounts - And more! This is a 7 month temporary position at 40 hours per week. JOB DESCRIPTION Essential Duties and Responsibilities · Work with the Purchasing and Supplier Management group to ensure timely review and approval of supplier notice of change (SNC) packages and the Decommissioning (DEC) process. · Support of the SNC/DEC process by reviewing older SNC/DEC projects and assisting the project leader/DEC Subject Matter Expert (SME) in driving the projects to closure. This may include creating project schedules, assisting in change control documents, supporting Exception documents, supporting the writing and execution of CAPAs, or other related project activities. Ø Issue resolution related to SNC/DEC project management. Ø Support various SNC/DEC process improvements. Ø Attend meetings, participate in conference calls, and generate written status reports and/or final written reports at the direction of Program Manager. Ø Assist in development of a system to expedite closure of aging SNC/DEC projects on an on-going basis. · Identifies new Supplier Quality Notice of Change and Decommissioning Improvement Initiatives / Projects based upon cGMP Expectations. · Interacts with all levels of company management across function, business units, and project teams to provide guidance and input on Supplier Quality topics. Identifies company supplier requirements; helps to resolve issues in a timely manner. · Serve as primary interface and resources for division/region supplier quality resources. Qualifications · Knowledge of the global Regulatory and Quality requirements for the manufacture and marketing of drugs, biologics and medical devices. · Knowledge of new product development processes, requirements and issues related to the evaluation, selection and maintenance of suppliers. · Knowledge of supplier quality related contract requirements · Demonstrated experience interfacing with FDA/Regulatory Inspectors · Strong leadership skill and demonstrated success in managing a team · Ability to respond to customers in a timely manner · Excellent verbal and written communication skills · Demonstrated success working with multifunctional, global teams within and external to company · Excellent interpersonal/communication/influencing/negotiation skill · Ability to make quick, sound, decisions with limited data · Ability to solicit feedback and information from others in an open environment · Ability to build relationships across functional boundaries at multiple levels internally and externally. Education and/or Experience Minimum of Bachelor?s degree and 1-3 years relevant experience. For immediate consideration, click the "Apply Now! button, or refer a friend by clicking the "E-mail this job" link provided. Kelly Services, Inc. is an Equal Opportunity Employer. Kelly Services connects professionals with opportunities to advance. As the local offices of Kelly Services do not represent the above position, please apply on-line for immediate consideration. For questions regarding this position, please email or phone 4117@kellyservices.com or 732-246-1396.