QA Principal Operations Specialist Lv. 3

Lonza, Inc. Portsmouth, NH
At Lonza, we invest in great people. We encourage our employees to challenge themselves and we offer an environment that fosters creativity and success. Headquartered in Basel, Switzerland, we operate production, R&D, and business sites around the world, including Europe, North America, and Asia. Our vision: We strive to be the leading supplier using science and technology to improve the quality of life. Our mission: We work with passion, using advanced technologies, to transform life science into new possibilities for our customers. Do you want to help us as we shape the future of this great organization? Job Description Summary The CT QA Operations Specialist must have significant quality experience and be able to provide oversight and guidance for multiple concurrent cell Therapy programs. The individual who fills this role will be a strong partner with the CT Operations group, customers, and the site Quality Systems group. Key functions include on-the-floor QA support, batch record review, deviation review and approval, change control, and review of procedures and Master Batch Records. Prior experience in cell therapy and/or aseptic processing is desired, but not essential. A strong foundation in application of GMPs in a drug substance or drug product manufacturing environment is critical, as is an ability to quickly assess facts and make the appropriate decision when process/product quality may be impacted. As CT is a relatively new field, the incumbent must be able to appropriately apply GMPs for biologics, drugs and medical HCTP to situations for which precedents have not been set. Responsibilities: Represents QA for internal and external project and team meetings. Provides Quality strategies to ensure compliance with regulatory requirements and to minimize quality issues. Interfaces with customers and internal groups for resolution of quality issues. Has decision-making authority for all but the most complex of Quality issues. Responsible for facilitating and reviewing/approving change controls and deviation investigations, and for ensuring that change controls, investigations and CAPA meet regulatory requirements. Interfaces with customers for review and approval of change controls and deviation investigations. Maximizes the efficiency and quality of change control and investigation packages such that project and delivery timelines are met Reviews and approves Master Batch Records, SOPs, study protocols and summary reports, forms, etc. relevant to manufacture of cell therapy products. Reviews to ensure that procedural requirements for generation, review, approval and revision of documents are adhered to, with subject matter experts being responsible for technical content for all documents other than those documents specific to QA activities. With the site Inspection and Audit management group, interfaces with customers and regulatory agencies in the management and response to internal audits and regulatory inspections. Perform other duties as assigned. Requirements Knowledge, skills and education: Bachelor's Degree, Preferred area of study: Life sciences Typically 36 months of experience in QA Operations in a position with significant responsibilities and a demonstrated history of independent decision-making : or 8+ years in a GMP environment inclusive of a diversified Quality background/experience This position is responsible for the widest range of decision-making, from simple to complex decisions. The incumbent must have the ability to independently assess quality issues and triage the majority of issues but also escalate to Senior management when appropriate Has solid understanding of cGMP and ICH guidelines and requirements Must possess a basic working knowledge and understanding of critical process steps and parameters, including cell culture and exposure to aseptic processing Understands the concept of product clearance through process changeover Knows the concept of deviation management and documentation Understands the TrackWise, SAP, LIMS, SAP, Syncade and Microsoft Office systems. Approach to work: Hard working, inquisitive, mentally-flexible and critical thinking are important qualities for the role. Ability to maintain a professional demeanor at all times. A positive attitude and an ability to adapt to, and embrace changed conditions are a big plus. Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law. Lonza. The place to Go, Stay and Grow.