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The position requires strong management and leadership skills as well as a deep understanding of biologics analytical GMP testing of clinical and commercial drug substance and drug product biological products, GMP raw materials inspection and release, and facility environmental monitoring programs.
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Leads and manages the plant's quality system by implementing and monitoring quality control procedures and SPC methods for both incoming raw materials and finished product.
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Make disposition of all raw materials, components, and finished products as directed by the Quality Systems Manager. The Quality Systems Supervisor will assist in directing and maintaining all daily operations of the Quality Assurance/Quality Control department.
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Supports QC Raw Materials team on internal tech transfer meetings related to new products. The role will be responsible for participating in the Technology Transfer of established methods into the FDBN Quality Control Laboratory.
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The QC Manager is primarily responsible for the regulatory compliant analytical testing of facilities, raw materials, intermediate, and final products for release, sale and distribution of product into these markets.
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What you will doThe Materials Manager Manages overall plant efforts to assure consistent, economical, and timely flow of both purchased and raw materials to support the manufacturing efforts of the facility to meet the customer’s needs and expectations by performing duties personally or through subordinate supervisors and/or support personnel.
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Knowledge of raw materials, production processes, quality control, costs, and other techniques for maximizing the effective manufacture and distribution of goods. Inspect, test, sort, sample, or weigh nonagricultural raw materials or processed, machined, fabricated, or.
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Oversee Document Control and lead Change Control (formulas, raw materials, and packaging materials) systems. Experience with quality assurance software that allows integration of product development, quality control (testing specs), quality assurance, project management, purchasing, as external vendors.
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Performs sampling and laboratory testing of raw materials, in-process samples and finished drug product analysis, using standard techniques in biochemistry, molecular biology and cell biology, and according to approved test methods.
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The role is also responsible for effective collaboration with several stakeholders including but not limited to: Manufacturing, MSAT, Process Engineering, Process Development, Quality Assurance, Process Sciences, Regulatory, CMC teams, Facilities, Validation, Supply Chain, Quality Control, and various vendors.
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The Material Manager will be responsible for managing materials used in gene therapy manufacturing including single-use consumables, raw materials, and packaging materials.
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As a key member of the plant management team, the Quality Assurance Manager works closely with all aspects of the manufacturing process, from raw materials to finished product, and provides Quality Assurance and Continuous Improvement guidance as a subject matter expert.
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Quality inspection, Production, manufacturing, organizational skills, computer skills, MRP, ERP, Inspection, Quality control, Quality assurance, Quality check, Qa, Visual inspection, Blueprint, Micrometer, Calipers, Height gauges, Cmm, measurement tools.
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Manages the Product Assurance Policy for Spring Grove Mill grade portfolio by developing and maintaining systems for measuring and reporting the incoming quality level of raw materials and for making disposition decisions for out-of-specification material.
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The Materials Manager is responsible for managing overall plant efforts to ensure a consistent, economical and timely flow of both purchased and raw materials to support the manufacturing efforts of the facility to meet customers' needs and expectations by performing duties personally or through subordinate supervisors and/or support team members.
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