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Reporting to the Director, Quality Assurance, the Senior Manager/Associate Director, Quality Assurance will assist in the quality oversight and management of internal and external GXP Quality Systems including, but not limited to: Batch Record Review and Release, Investigations, CAPA, Product Quality Complaints, and external document review and approval.
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Responsible for Continuous Improvements of the BioLegend Quality Management System including: Management Review, Change and Document Control, Records Management, Validations, Audit and Inspection Management, Corrective and Preventive Action Management, Complaints, Failure Analysis, Risk Management per total product life cycle, Nonconformance Management, Distribution Quality, Supplier Quality, and Manufacturing Quality.
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Proficient in legal document review and quality control processes. Conduct thorough document reviews with a focus on quality control (QC) to ensure accuracy and compliance with legal standards.
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Manage periodic document review activities assisting CQCU and other Functional Owners to update content and confirm training requirements. Support Quality Management Review process at least twice per year.
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Works with Firm Administrator and Personnel Partner to enforce the adherence to Brickley DeLongs Quality Control Document and personnel policies with CAS employees. Services performed include, but are not limited to, the preparation and/or review of payroll tax returns, the development of trial balances, completion of bank reconciliations, preparation of monthly / quarterly / annual financial statements, resolution of payroll tax notices, training & professional development of CAS staff and frequent communication with clients to resolve bookkeeping errors & technical issues.
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Ensure that document control procedures are utilized to approve, review, and update all changes to critical documents within the scope of the QMS. Formulates quality control objectives for the facility, such as defect reduction and operator certification for specified quality tasks and coordinates the objectives with production management and manufacturing procedures to maximize product reliability and minimize costs associated with rework, scrap, and escapements.
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1+ years of document control experience (i.e. Supplier Documentation, Batch Records, Change Control, etc.) The job will primarily be computer/desk based doing document review and supplier documentation auditing.
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Proficiency with Quality by Design (QbD) concepts, statistical process control (SPC) and complex data analysis. Interface with Manufacturing, Packaging, and Engineering to facilitate and drive document review and approval.
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Demonstrates leadership through a commitment to communication, work habits and be fully competent in all aspects of a wide variety of processes including maintaining safety, troubleshooting/problem solving, decision making, organizing/planning, Nestle core behaviors, administrative, quality appraisals, sampling plans, manufacturing audits/process audits, statistical techniques, production control systems, manufacturing document review, test equipment and training.
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The Document Control Specialist is responsible for the tactical oversight and maintenance of document control system for a new Radiopharmaceutical facility in Indianapolis, IN. The Document Control Specialist will be a primary contact point for document control support.
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Possess a deep Quality Engineering toolbox including Design of Experiments, Process Capability Studies, Failure Mode and Effects Analysis, Statistical Process Control, Design for Six Sigma, Industrial Statistical Methods, Six Sigma and/or Lean Manufacturing.
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This position will be responsible to maintain the QMS, facilitate external and internal audits, ensure completion of nonconformances, CAPA’s, complaints, document control and change controls.
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Perform assigned inspection functions working from Quest and Supplier type design drawings, CAD models, Material Review Board (MRB) dispositions, Quest Process Specifications, material specifications, Purchase Order specifications, Federal Aviation Administration (FAA) Regulations, Quality Assurance Manual (QAM), approved industrial/commercial specifications, approved handbooks, Job Travelers, engineering/tooling /rework orders, and approved written/verbal instructions.
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Ensure that a document control procedure is adopted to approve, review and update all changes to critical documents within the scope of the Quality Management System (QMS.
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The Validation Scientist is a key member of the Technical Services team in Philadelphia and will perform Validation activities with a concentration on packaging validation, which includes process and cleaning validation, adhering to cGMP policies/procedures and Adare’s quality standards.
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