Principal Quality Associate, OSD Manufacturing
DSM - Greenville, NC

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NOTE: This position requires flexibility to support for 24/7 Manufacturing OperationsProvide technical leadership and Quality oversight to OSD Manufacturing by ensuring compliance with regulations that govern pharmaceuticals. Make decisions on issues of moderate to high complexity, while taking into account GMP risks and required regulations. Review/approve regulatory required documentation and ensure documentation and practices meet compliance and procedural requirements. Work as needed during and outside normal hours as necessary to support operations. Assist with and conduct investigations, audit actions, regulatory reporting, and compliant investigations as assigned. Work in various roles during regulatory audits, and provide support during customer and internal audits. Make decisions that ensure product is released for human/veterinary use meets requirements in regards to safety, quality, identity, purity, and potency. Ensure quality of methods, processes, materials, and products by providing coordination and review of group, staff training, and assessment/improvement of systems and processes. Conduct risk assessments and take appropriate actions during quality system management and oversight activities. Act as a technical resource for support of systems and new product introduction by proactively interpreting regulatory and compliance requirements, establishing, and maintaining systems. Perform QA batch disposition (release decisions). Comply with job-related safety and other training requirements. Work in a safe and responsible manner in order to create an injury-free and incident-free workplace. Perform other duties as assigned.

The Ideal MS in scientific/related field plus 3 years experience in the pharmaceutical industry. Or BS in scientific/related area plus 5 years experience in the pharmaceutical industry. Or AAS in related field plus 5 years of relevant experience. Experience must include leadership roles on high level projects. Certification as a Quality Engineer or Quality Auditor (CQE/CQA) is preferred. Thorough knowledge of GMPs as detailed in 21CFR Parts 210 and 211 and associated guidance documents. Ability to work on issues of moderate to highly complex in regards to compliance of processes and product within facilities, equipment, manufacturing, and support areas. Ability to make decisions while taking into account level of risks in regards to compliance and product quality. Ability to lead projects in scope and compliance-related challenges to implement procedures and processes to meet changing regulations. Multiple computer skills including working experience with MS Office applications such as Word and Excel and general experience in computer systems associated with quality assurance functions such as SOP review and approval, lab results reviews (LIMS), disposition of product (SAP) and validation document reviews. Must be willing to work as needed during and outside normal hours as necessary to support operations.

The Procedure and Contact DSM's wide diversity of disciplines makes it possible to offer employees a great variety of roles throughout their career. For instance, you may start your career in an area related to your education/qualifications, but your future is what you make of it. At DSM we stimulate people to determine their own career path and we encourage international careers. We strive to be an Employer of Choice and ensure that our employees are nurtured and given the opportunity to develop their talents. To learn more about DSM's HR vision and policy, please visit our website at We offer a challenging and rewarding job in an innovative multinational company with several opportunities for personal input and development; an open and dynamic atmosphere; a 'never-stop-learning' attitude. Terms and conditions of employment as well as fringe benefits are market competitive.The Procedure: Please apply online at The procedure is in line with what you can expect from an Equal Opportunity Employer. DSM participates in E-Verify.

DSM - 17 months ago - save job - block
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DSM wants to get more out of life, or at least life and material sciences. It focuses on nutritional products and performance materials,...