QA Compliance Specialist LVL 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 We have a great opportunity for an experienced QA Compliance Specialist to join our Quality Assurance team in beautiful Portsmouth on the NH seacoast. As a QA Compliance Raw Materials Specialist, your main responsibility will be to interact directly with Lonza’s internal customers for disposition of materials. Using a deeper understanding of cGMP documentation, you will review material release documentation as well as other ancillary attachments such as vendor technical documentation, certificate of analysis/compliance and confirmatory test results, in order to ensure the timely release of raw material for production. Due to your established understanding of the material receipt, testing and disposition process, you will be expected to resolve complex issues, triage issues for escalation to Lead Specialists and train junior staff members. You will also provide input on issues within their area of responsibility to Lead Specialists or management for resolution and/or improvements. You will be expected to perform all associated SAP transactions as part of the release as well as other Quality functions within SAP. Key Responsibilities: Interact with internal customers for disposition of materials. Reviewing and revising various material specific documents, as needed. Perform other duties as assigned. Must know and follow job safety procedures, attend required health and safety training, proactively promote safety at work, and promptly report actual and potential accidents and injuries. Must comply with safety policies of the company and site. Adherence to cGMPs is required at all times during the manufacture of APIs. All personnel own the quality of what they deliver and are responsible for notifying responsible management in a timely manner of regulatory inspections, serious GMP deficiencies, process deviations, product defects and related actions. High output while multi-tasking required Interested? What we need you to have: Degree or equivalent experience. Preferred area of study: Scientific related field. Significant experience in GMP environment preferred. Biotechnology manufacturing background is preferred. Several years in a Quality role. Demonstrated knowledge of GMP’s and regulations Experience with TrackWise, SAP, Syncade and Microsoft Suite preferred Demonstrated self-starter, Excellent written and verbal communicator at all levels, Demonstrated ability to tolerate challenging workloads and changing priorities Strong attention to detail Demonstrated ability to work effectively individually and with teams 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.