Quality Control Systems Lead
Quality Control Systems Lead
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Mammalian
Microbial
ADCs / Bioconjugates
Drug Product
mRNA / LNP
Expression Technologies
Small Molecules
Drug Substance (API)
Particle Engineering
Drug Product
Cell & Gene
Process Development
cGMP manufacturing
Allogeneic
Autologous
Viral Vectors
Bioscience Products
Capsules & Health Ingredients
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Quality Control Systems Lead
United States, Greenwood (South Carolina)
Quality Control Systems Lead Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of. The Quality Control Systems Lead is Responsible for managing the logistical functions associated with the daily operation of the Quality Control laboratories. Supervises the colleagues responsible for sampling raw materials. Maintains documents and records, coordinates the receipt and storage of all raw materials, and assists in communicating the needs of the business to the Quality Control Laboratories. Key responsibilities: Manages the raw material sampling program for the Hard Capsule, Liquid Filled Capsule, and Ingredients businesses on-site through the supervision of those responsible with performing sampling. (documentation, delivery, shipping, storage, etc.) Schedules material movements with warehouse and logistics team and executes raw material usage decisions in the SAP system. Coordinates raw material sampling and testing priorities with multiple cross-functional teams for each on-site business. Supervises the generation of testing documentation (working papers, test forms, and sample labels) Communicates pre-ship sample approvals with suppliers and global teams as needed. Responsible for creating and maintaining QIR (Quality Information Records) and QM (Quality Management) information for raw materials in SAP ERP system. Supervises the scanning/filing/storage/archival of physical and electronic documentation. (analysis documents, calibration certificates) Manages the raw material retain sample program. Responsible for creating logbooks for lab testing and monitoring. Manages annual and quarterly samples received for Global Testing program and responsible for pulling Greenwood site samples quarterly. Supervises the submission and shipment of samples to contract labs for 3rd party testing. Manages internal and external requirements for ISO 17025 certification, including but not limited to: proficiency testing or inter/intra-lab comparison testing, internal auditing schedule, scope of certification, and recertification. Manages requests and submitting required documentation for IFANCA Halal certifications. Manages instrument and equipment calibrations and maintenance (scheduling, software, payment, etc.) Oversees management of laboratory supplies, chemicals and equipment (requisitions, direct buying) Responsible for departmental office supplies (inventory and ordering) Managing PPE Supplies for QC colleagues through external providers Responsible for communicating janitorial and facility maintenance needs to completion in the laboratory and office area. Must be able to work 40 hours a week, which may include weekends, holidays, etc. Must be able to work additional hours/days as business needs dictate Attendance in the plant site is considered an essential function Perform other duties as assigned. Key requirements: Associate degree or 5 years of administrative experience Experience in a quality oriented field Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically. People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference. 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.
Reference: R57841
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