Complaint Handling • Work with multifunctional teams (R&D, Manufacturing, Operational Compliance, and Engineering to drive resolution to product complaints Verification, Validation and Qualification • Provide support for the development of validation strategies and validation plans • Review / approve protocols and reports o Design verification o Process validation o Cleaning validation o Facility/cleanroom validation o Equipment qualification JOB DESCRIPTION SUMMARY This position is responsible for providing quality and technical support to the production team providing oversight to manufacturing rooms and laboratories by reviewing and approving data and all other Quality Management System documentation. The position utilizes risk management, quality planning and statistical analysis to complete assigned tasks. PRINCIPAL ACCOUNTABILITIES Routine Quality Assurance functions, to include but not limited to: Manufacturing Support Provide real time production floor QA oversite Evaluate manufacturing data for trends and other special causes Review and disposition manufacturing / packaging batch documentation Perform room / line clearances as needed Review and disposition raw materials / components for manufacturing Support resolution of quality issues in manufacturing Product and Process Development Represent quality department on development project teams Review and approve product and process-related documentation Support the generation and justification of product and materials specifications Deviations/ CAPA Support Deviation / CAPA investigations Support interdisciplinary teams for root cause analysis of quality deficits using known of problem solving tools Failure reports for products in the field Identification of potential failure modes and risks Resolving of customer issues appropriately Continuous Improvement Support product quality and System improvements activities Support collection and analyze data to identify opportunities for quality improvement Complaint Handling Work with multifunctional teams (R&D, Manufacturing, Operational Compliance, and Engineering to drive resolution to product complaints Risk Management Support to facilitate risk assessment activities such as design and process FMEA Ensure product risks are identified and risk mitigation controls are put in place to eliminate product risk to an acceptable level Verification, Validation and Qualification Provide support for the development of validation strategies and validation plans Review / approve protocols and reports Design verification Process validation Cleaning validation Facility/cleanroom validation Equipment qualification REQUIREMENTS Bachelor of Science degree in Chemistry, Biology, or Engineering, preferred. Minimum two to three years’ experience in pharmaceutical or medical device manufacturing Minimum two to three years’ experience in a pharmaceutical or medical device Quality Assurance role Proficient computer skills, Microsoft Word, Excel, Access High attention to detail, organization, and accuracy Strong written and verbal communication skills Good interpersonal skills Knowledge or understanding of FDA’s cGMP and / or QSR quality system requirements Experience in Regulatory Agency inspections, preferred Experience in aseptic techniques and manufacturing, preferred. Your Application To ensure that your application is proceeded as quickly as possible and to protect the environment, please apply online via our careers portal. Further information about Evonik as Employer can be found at https://careers.evonik.com. Please address your application to the Talent Acquisition Manager, stating your earliest possible starting date and your salary expectations. Your Talent Acquisition Manager: Vincent Szewczyk [C] Company is Evonik Corporation This is your opportunity to join a thriving global organization that combines cutting-edge science, technology and engineering with world-class business services to create solutions that answer real-world problems. If you join us, we’ll expect you to take ownership of your work, team up with other great minds, and add your name to creations that make a positive difference for generations. As one of the world leaders in specialty chemicals operating in more than 100 countries with over 32,000 employees, we need your diversity of thought to make us better. In return for your passion, initiative and creativity, you’ll enjoy opportunities to improve and to be respected for your contribution. Click here to learn more about Evonik from our employees.