- Butterball (Clinton, NC)
- …all internal policies and practices are completed and documented appropriately. Ensures compliance with all FDA and regulatory requirements, including necessary ... feed production process* Firm understanding of safety and regulatory compliance standards in manufacturing* Administrative experience within logistics and/or… more
- Cytiva (Pensacola, FL)
- …therapeutics from discovery to delivery.What you will do:Quality Leadership & Compliance : Serve as the Pensacola site's Quality Management Representative, leading ... QA/QC functions, ensuring regulatory compliance , and aligning with organizational quality goals.Quality Management System (QMS): Implement, maintain, and optimize… more
- Beckman Coulter Diagnostics (Miami, FL)
- … with local, state and federal environmental regulations and standards including compliance with Food & Drug Administration ( FDA ), Medical Device Single ... position is part of the Global Quality System and Compliance Group located in Brea, California, USA and will...submission of audit responses and requests for information to FDA , MDSAP Notified Body and other Regulatory Bodies.Utilize Danaher… more
- Cytiva (Miami, FL)
- …or systems to increase production capacity and improve process performance ensuring compliance with regulatory requirements (eg, FDA , ISO, PSM) and contribute ... device production.2+ years experience with regulatory standards and quality systems (eg, FDA , ISO 13485, Good Manufacturing Practices - GMP).2+ years experience with… more
- Pall (Miami, FL)
- …and/or procedures advises on impact of regulations, devises strategies for compliance , and liaison with regulatory bodies. Investigates and resolves compliance ... and complaints. Audits and evaluates current policies, procedures, and documentation for compliance with regulations and statutes. Determine the need for and prepare… more
- Aldevron (Miami, FL)
- …format, and placement adhere to these requirements throughout the product lifecycle. Ensure compliance with labeling regulations, such as 21 CFR Part 210, 211, 610, ... Develop and maintain robust labeling processes and procedures to ensure compliance , accuracy, and consistency of labeling across product lines which includes… more
- Aldevron (Miami, FL)
- …creation, implementation and maintenance of all Quality and release processes in compliance with all foreign and domestic regulatory and statutory requirements. This ... primary contact with both customers and regulatory agencies regarding quality/ compliance issues and Negotiate Quality AgreementsDevelop and enhance phase appropriate… more
- Butterball (Mount Olive, NC)
- …chemicals necessary for the operation of the cleaning program and in compliance with OSHA and all plant regulations.Assists operations to maintain the highest ... maintain and promote a safe work environment.Read and understand HACCP along with FDA and OSHA requirements as needed.Education & Experience: High School Diploma or… more
- Butterball (Mount Olive, NC)
- …chemicals necessary for the operation of the cleaning program and in compliance with OSHA and all plant regulations.*Assists operations to maintain the highest ... maintain and promote a safe work environment.Read and understand HACCP along with FDA and OSHA requirements as neededProven ability to work in a fast-paced and… more
- Butterball (Mount Olive, NC)
- …chemicals necessary for the operation of the cleaning program and in compliance with OSHA and all plant regulations.*Assists operations to maintain the highest ... maintain and promote a safe work environment.*Read and understand HACCP along with FDA and OSHA requirements as needed*Proven ability to work in a fast-paced and… more
- Beckman Coulter Diagnostics (Miami, FL)
- …(both formal classroom and informal) to ensure efficiency and compliance with validation regulations and corporate procedures.Evaluate specifications for ... test method, equipment, process, and/or design testing methodologies.Knowledge of FDA regulations, ISO standards, and GxP guidelines.Experience with Computer System… more
- Aldevron (Miami, FL)
- …risk assessment using FMEA, HCCAP, and Quality by Design in compliance with Aldevron and cGMP policies, procedures, rules, and regulations.Job QualificationsBachelor ... experience.Exposure to regulatory agency inspections or other types of audits (eg, FDA , notified bodies, ISO, etc.).Current or past Quality certifications a plus (eg… more
- Cytiva (Duncan, SC)
- …control processes related to contamination controls and sterility assurance.Ensure compliance with regulatory requirements and industry standards for sterility and ... and industry standards for sterility assurance and contamination control (eg, FDA , EMA, ISO).Proven experience in developing and implementing sterility assurance… more
- Kelly Services (Gillette, WY)
- …therapies. You will collaborate with internal teams and external partners to ensure FDA compliance and successful product development from concept to market. ... teams to meet safety and efficacy standards. **Regulatory and Compliance Expertise:** + Lead FDA strategy and submission efforts for INDs, IDEs, and other… more
- University of Michigan (Ann Arbor, MI)
- …ensure adherence to regulatory requirements, standards and best practices. + Oversee compliance with upcoming FDA Laboratory test development regulations. + Work ... care administration, regulatory affairs, or related. Previous experience in laboratory compliance . FDA medical device or related experience. Demonstrated ability… more
- Abbott (New York, NY)
- …Quality System and regulatory practices across their group to achieve divisional and FDA compliance , work with Quality groups to establish, and improve quality ... employees are trained and follow established policies and procedures, ensures OEC compliance with transactions of goods and services. **Decision making:** + Makes… more
- Actalent (Minneapolis, MN)
- …software, Test automation, Automated testing, sterilization, failure analysis testing, failure analysis, capa, fda , fda compliance , iso 13485, iso 14971, iso ... with design and manufacturing teams to ensure product quality and compliance with regulatory, customer, and internal requirements. Key Responsibilities: + Quality… more
- Actalent (Brooklyn Park, MN)
- …software, Test automation, Automated testing, sterilization, failure analysis testing, failure analysis, capa, fda , fda compliance , iso 13485, iso 14971, iso ... Ensure desired design and product performance requirements are met in compliance with applicable regulatory, customer, and internal requirements. Skills in other… more
- Terumo Medical Corporation (Campbell, CA)
- …+ Process validation experience; experience in validating product manufacturing processes to FDA compliance . + Ability to Maintain Quality Systems; collaborate ... Summary** Senior Manager, Quality has primary responsibility for establishing and maintaining compliance of Kalila Medical's (KMI) processes and procedures to the … more
- Teva Pharmaceuticals (Parsippany, NJ)
- …submissions (ie ANDAs, amendments, supplements, etc.) to the Food and Drug Administration ( FDA ) to ensure compliance with applicable regulations and guidance. + ... and risks to management appropriately. + Lead preparation for meetings with FDA including defining questions and all supporting information for Pre-ANDA meeting with… more
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