2 jobs found in libertyville, illinois

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    • libertyville, illinois
    • permanent
    • US$75,000 - US$80,000, per year, $75k - 80k per year
    • 9 to 5
    job summary:The Coordinator is responsible for performing duties associated with regulatory affairs and compliance requirements relevant to client. He/she ensures the accuracy and compliance with all governmental regulations for products by keeping track of the ever-changing legislation, presenting registration documents to regulatory agencies and maintaining marketing authorization. The incumbent reviews marketing, legal, and technical documentation, to assess compliance with global regulatory agency policies, regulations, and standards. location: Libertyville, Illinoisjob type: Permanentsalary: $75,000 - 80,000 per yearwork hours: 9 to 5education: Bachelors responsibilities:Prepares ingredient lists (ILNs) and initiating MSDSs for existing and new formulationsReview all formulation for global complianceMonitors reformulationsUnderstanding of cosmetics/ cosmetics tools regulations as it relates to ingredients and finished productPrepares and sends out all required foreign regulatory product registration documents to support desired market growthConfirms new product formulations for ingredient acceptability and works with Packaging Operations on packaging and environmental compliance as neededAdministers and maintains the Company's Annual Product Review including generating the reports.Supports administering and maintaining the Company's Documentation Change Control System for compliance documentation.Monitors regulatory activities (via searches of government internet web sites, review of USP supplements, Federal Register publications, and other government communication vehicles) and proactively presents, advises, and executes internal programs associated with these activities.Assists in maintaining master file documentation and databases.Administers the adherence to procedural requirements in the development of Master Records.Uses regulations to develop compliant information including active ingredients and concentrations, uses, warnings, directions, and inactive ingredients.Maintains facility licenses and drug listings.Supports the development and implementation of regulatory strategies, approval schedules, and submission standards to achieve department, and organization objectives.Interfaces with international third parties to ensure regulatory compliance.Interfaces with Product Development team and provides support in the compilation and submission of records for new product launches and market-specific registrations. qualifications:A 4-year technical college degree in a specialized field such as science or technology; or equivalent in knowledge and training.5+ years of experience in a pharmaceutical, regulatory environment.Knowledge of chemistry and broad cosmetics/drug regulatory experienceAttention to detail and ability to work well under pressure.Effective interpersonal skills to interact with various levels of internal and external customers.Excellent oral and written communication skillsComputer literacy in a Windows environment (Word, Excel, and Outlook).Ability to prepare detailed and accurate documentation.Familiarity with FDA regulations and monograph system as they relate to OTC drug products.Working knowledge of Current Good Manufacturing Practices (cGMP).Strong organizational and analytical abilities.Ability to work independently and meet deadlines on a multitude of concurrent tasks.Willingness to accept other duties, as assigned.Discretion with confidential information.Ability to develop and maintain an effective working relationship, function as a team player, accept constructive criticism from management, and comply with Company policies. skills: Regulatory Affairs OperationsEqual Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
    job summary:The Coordinator is responsible for performing duties associated with regulatory affairs and compliance requirements relevant to client. He/she ensures the accuracy and compliance with all governmental regulations for products by keeping track of the ever-changing legislation, presenting registration documents to regulatory agencies and maintaining marketing authorization. The incumbent reviews marketing, legal, and technical documentation, to assess compliance with global regulatory agency policies, regulations, and standards. location: Libertyville, Illinoisjob type: Permanentsalary: $75,000 - 80,000 per yearwork hours: 9 to 5education: Bachelors responsibilities:Prepares ingredient lists (ILNs) and initiating MSDSs for existing and new formulationsReview all formulation for global complianceMonitors reformulationsUnderstanding of cosmetics/ cosmetics tools regulations as it relates to ingredients and finished productPrepares and sends out all required foreign regulatory product registration documents to support desired market growthConfirms new product formulations for ingredient acceptability and works with Packaging Operations on packaging and environmental compliance as neededAdministers and maintains the Company's Annual Product Review including generating the reports.Supports administering and maintaining the Company's Documentation Change Control System for compliance documentation.Monitors regulatory activities (via searches of government internet web sites, review of USP supplements, Federal Register publications, and other government communication vehicles) and proactively presents, advises, and executes internal programs associated with these activities.Assists in maintaining master file documentation and databases.Administers the adherence to procedural requirements in the development of Master Records.Uses regulations to develop compliant information including active ingredients and concentrations, uses, warnings, directions, and inactive ingredients.Maintains facility licenses and drug listings.Supports the development and implementation of regulatory strategies, approval schedules, and submission standards to achieve department, and organization objectives.Interfaces with international third parties to ensure regulatory compliance.Interfaces with Product Development team and provides support in the compilation and submission of records for new product launches and market-specific registrations. qualifications:A 4-year technical college degree in a specialized field such as science or technology; or equivalent in knowledge and training.5+ years of experience in a pharmaceutical, regulatory environment.Knowledge of chemistry and broad cosmetics/drug regulatory experienceAttention to detail and ability to work well under pressure.Effective interpersonal skills to interact with various levels of internal and external customers.Excellent oral and written communication skillsComputer literacy in a Windows environment (Word, Excel, and Outlook).Ability to prepare detailed and accurate documentation.Familiarity with FDA regulations and monograph system as they relate to OTC drug products.Working knowledge of Current Good Manufacturing Practices (cGMP).Strong organizational and analytical abilities.Ability to work independently and meet deadlines on a multitude of concurrent tasks.Willingness to accept other duties, as assigned.Discretion with confidential information.Ability to develop and maintain an effective working relationship, function as a team player, accept constructive criticism from management, and comply with Company policies. skills: Regulatory Affairs OperationsEqual Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
    • libertyville, illinois
    • permanent
    • US$56,000 - US$58,000, per year, $56k - 58k per year
    • 11 to 7
    job summary:Technician, Maintenance and Reliability Night Shift - 6pm - 6amThe Technician, Maintenance and Reliability, performs all maintenance functions on production and facilities equipment for our Manufacturing facility. location: Libertyville, Illinoisjob type: Permanentsalary: $56,000 - 58,000 per yearwork hours: 11 to 7education: Associate responsibilities:Responsibilities:Routine inspection and repair or replacement of defective or faulty parts on machines and related equipment.Ensuring good workmanship with minimum delay.Support the safe and effective operation of the plant and the facility.Perform preventive and predictive maintenance on production equipment and utility systems.Scope, plan, and execute repairs to and installation of plant machinery.Coordinate with site departments daily appropriate course of action to maximize uptime and quality performance of respective area.Operate machinery for purposes of training, troubleshooting, or as needed to support production activities.Initiate and participate in documented troubleshooting studies on equipment to outline opportunities for improvements.Document clear problem description, symptom, root cause and solution.Proven reasoning, troubleshooting and analytical thinking skills.Use shop equipment to repair or modify parts and equipment.Knowledge of, perform preventive maintenance, troubleshoot, and repair: qualifications:Qualifications:Technical school education in the areas of Manufacturing Engineer, Mechanical Engineering Technology, Electrical Engineering Technology or 2 years equivalent education/experience.Proficient in using personal computers and a working knowledge of software such as MS Excel and Word.Ability to analyze, investigate and help solve equipment technical issues.Good communication skills, both verbal and written.Must be flexible to work nights, weekends, and holidays as required.Ability to work with very minimum supervision.Must be proactive.Must have a good attitude regarding safety and lock out proceduresProven experience in machine maintenance and troubleshooting skills.Good understanding of GMPs with experience in pharmaceutical environment.Read and understand mechanical and assembly drawings, hydraulic/pneumatic, and electrical schematics.Read and understand P&ID (Piping & Instrumentation Diagram).Occasionally lift and/or move up to 50 pounds. skills: GMP (Good Manufacturing Practice)Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
    job summary:Technician, Maintenance and Reliability Night Shift - 6pm - 6amThe Technician, Maintenance and Reliability, performs all maintenance functions on production and facilities equipment for our Manufacturing facility. location: Libertyville, Illinoisjob type: Permanentsalary: $56,000 - 58,000 per yearwork hours: 11 to 7education: Associate responsibilities:Responsibilities:Routine inspection and repair or replacement of defective or faulty parts on machines and related equipment.Ensuring good workmanship with minimum delay.Support the safe and effective operation of the plant and the facility.Perform preventive and predictive maintenance on production equipment and utility systems.Scope, plan, and execute repairs to and installation of plant machinery.Coordinate with site departments daily appropriate course of action to maximize uptime and quality performance of respective area.Operate machinery for purposes of training, troubleshooting, or as needed to support production activities.Initiate and participate in documented troubleshooting studies on equipment to outline opportunities for improvements.Document clear problem description, symptom, root cause and solution.Proven reasoning, troubleshooting and analytical thinking skills.Use shop equipment to repair or modify parts and equipment.Knowledge of, perform preventive maintenance, troubleshoot, and repair: qualifications:Qualifications:Technical school education in the areas of Manufacturing Engineer, Mechanical Engineering Technology, Electrical Engineering Technology or 2 years equivalent education/experience.Proficient in using personal computers and a working knowledge of software such as MS Excel and Word.Ability to analyze, investigate and help solve equipment technical issues.Good communication skills, both verbal and written.Must be flexible to work nights, weekends, and holidays as required.Ability to work with very minimum supervision.Must be proactive.Must have a good attitude regarding safety and lock out proceduresProven experience in machine maintenance and troubleshooting skills.Good understanding of GMPs with experience in pharmaceutical environment.Read and understand mechanical and assembly drawings, hydraulic/pneumatic, and electrical schematics.Read and understand P&ID (Piping & Instrumentation Diagram).Occasionally lift and/or move up to 50 pounds. skills: GMP (Good Manufacturing Practice)Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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