Zoetis Spain SL
Quality Assurance Specialist I
Zoetis Spain SL, Chicago, Illinois, United States, 60290
Quality Assurance Specialist I
Apply locations Chicago Heights time type Full time posted on Posted 2 Days Ago job requisition id JR00016193This position supports quality operations, compliance systems and objectives within the Chicago Heights, IL site. The candidate maintains a quality mindset and implements continuous improvement efforts and quality system initiatives to industry requirements. This position will interact with cross-functional groups such as Quality Control, Production, and Regulatory Affairs.POSITION RESPONSIBILITIES:Provide in plant/on floor support and guidance for cGMP product quality assurance and compliance for Manufacturing Operations and warehouse activities. Supply manufacturing and packaging operations Quality oversight – supplying the WHY as well as the HOW Quality is applied.Ensure approved quality systems are established and maintained.Identify and communicate potential compliance gaps / risks to management.Ability to provide Quality oversight on the manufacturing floor, including assessing deviations, incidents, and other compliance support.Support and approve Manufacturing/Event Investigations and Corrective, Preventative Action (CAPA) and Laboratory Investigation records.Educate and mentor site personnel on quality system requirements to achieve compliance goals.Supports training management system and assists with new employee, cGMP, refresher and general training.Maintains and/or monitors compliance tracking systems and archive records, e.g., document control, deviation reporting, calibration, records retention, records destruct, etc.Coordinates and investigates customer and supplier complaints.Understands and follows Pharmaceutical GMP regulations.Supports the release of finished goods documentation including technical review of batch records, labeling, COA, reprocessing instructions and lot deviations.Supports product release and inventory management activities.Ensure that Product release is in compliance with the registration files.Assist in the development or edit of new/revised standard operating procedures, forms, flow diagrams, specifications, etc.Assist in facilitation, organization, and reporting of site FDA and regulatory compliance inspections. Assist with developing remediation efforts and FDA response when necessary.Uphold a state of constant inspection readiness at the site.Perform internal compliance, surveillance and focused audits. Develop and maintain audit plan and prioritize audit focus points, conduct reviews of technical documentation, identify risks, determine actions and prepare final report.Provide support of the supplier management program including supplier audits and qualification of new suppliers.Attend training to update personal skills and knowledge level.Proactively and continuously improves Zoetis’ internal processes and products with quality mindset.Provide Regulatory Affairs compliance support and review on regulatory submissions, approvals, product labeling, registrations and other projects as needed.Performs technical reviews and approves validation documents, design review, engineering reviews, IQ/OQ/PQ, quality support reports, protocols, final reports and miscellaneous project documentation.Provides compliance and regulatory support for existing process, new products and processes, design review, construction and installation, and implementation.Ability to develop and communicate technical information with internal and external customers including regular weekly/monthly reporting activities.Provide support with document control and learning management system functions.Support the timeliness and effectiveness of the Site completion of Annual Product Reviews (APRs) through report compilation and review.Assure the use of operational excellence tools in quality procedures and processes and Drive continuous improvement initiatives which positively impact process performance and product quality throughout the product lifecycle and provide assurance of continued suitability and capability of processes through Lean methodology and QRM Principles.Through Key Quality Performance Indicator (KPI) Dashboard, monitor and report Site quality systems performance.Provide support with site data integrity assessments and actions, as well as computer system validation (CSV) plans and execution.Assist in mock recall activities for the site.Provide support in maintaining the Food Safety Plan for the manufacturing site.Other duties as assigned by Quality Management.EDUCATION AND EXPERIENCE:BS degree in a scientific field is required.A minimum of 2 years related experience preferably in an FDA regulated industry.Requires approximately 10% domestic travel and occasional international travel.Must possess strong oral and written communication skills and the ability to work independently.Must have a strong understanding of GMP and global regulatory standards.CQA certification, Lean Six Sigma Qualification, PCQI desired.TECHNICAL SKILLS REQUIREMENTS:Fluency in quality operations, systems and regulatory compliance.Demonstrated written communication skills, as well as experience with presenting to leadership teams.Strong interpersonal and communication skills; ability to communicate across all levels of the organization.May contact vendors and/or external customers for administrative and technical information.Excellent attention to detail and strong time management skills.PC literate with the following applications: MS Excel, Word, Power Point.Ability to manage multiple projects simultaneously and prioritize work, goals and tasks in accordance with division and corporate objectives.Driven / Passionate about Quality performance and delivering results.Fluent in English (written and spoken).Inspires Continuous Improvement and Breakthrough Thinking – utilizing problem solving tools such as Lean and Six Sigma.PHYSICAL REQUIREMENTS:The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.While performing the duties of this job, the employee is regularly exposed to a laboratory, office and/or manufacturing setting. Incumbent must be able to access all areas of the facility and is required to utilize certain Personal Protective Equipment, including but not limited to, hard hats, safety (“steel-toed”) shoes, eye protection, gloves, and protective clothing.
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Apply locations Chicago Heights time type Full time posted on Posted 2 Days Ago job requisition id JR00016193This position supports quality operations, compliance systems and objectives within the Chicago Heights, IL site. The candidate maintains a quality mindset and implements continuous improvement efforts and quality system initiatives to industry requirements. This position will interact with cross-functional groups such as Quality Control, Production, and Regulatory Affairs.POSITION RESPONSIBILITIES:Provide in plant/on floor support and guidance for cGMP product quality assurance and compliance for Manufacturing Operations and warehouse activities. Supply manufacturing and packaging operations Quality oversight – supplying the WHY as well as the HOW Quality is applied.Ensure approved quality systems are established and maintained.Identify and communicate potential compliance gaps / risks to management.Ability to provide Quality oversight on the manufacturing floor, including assessing deviations, incidents, and other compliance support.Support and approve Manufacturing/Event Investigations and Corrective, Preventative Action (CAPA) and Laboratory Investigation records.Educate and mentor site personnel on quality system requirements to achieve compliance goals.Supports training management system and assists with new employee, cGMP, refresher and general training.Maintains and/or monitors compliance tracking systems and archive records, e.g., document control, deviation reporting, calibration, records retention, records destruct, etc.Coordinates and investigates customer and supplier complaints.Understands and follows Pharmaceutical GMP regulations.Supports the release of finished goods documentation including technical review of batch records, labeling, COA, reprocessing instructions and lot deviations.Supports product release and inventory management activities.Ensure that Product release is in compliance with the registration files.Assist in the development or edit of new/revised standard operating procedures, forms, flow diagrams, specifications, etc.Assist in facilitation, organization, and reporting of site FDA and regulatory compliance inspections. Assist with developing remediation efforts and FDA response when necessary.Uphold a state of constant inspection readiness at the site.Perform internal compliance, surveillance and focused audits. Develop and maintain audit plan and prioritize audit focus points, conduct reviews of technical documentation, identify risks, determine actions and prepare final report.Provide support of the supplier management program including supplier audits and qualification of new suppliers.Attend training to update personal skills and knowledge level.Proactively and continuously improves Zoetis’ internal processes and products with quality mindset.Provide Regulatory Affairs compliance support and review on regulatory submissions, approvals, product labeling, registrations and other projects as needed.Performs technical reviews and approves validation documents, design review, engineering reviews, IQ/OQ/PQ, quality support reports, protocols, final reports and miscellaneous project documentation.Provides compliance and regulatory support for existing process, new products and processes, design review, construction and installation, and implementation.Ability to develop and communicate technical information with internal and external customers including regular weekly/monthly reporting activities.Provide support with document control and learning management system functions.Support the timeliness and effectiveness of the Site completion of Annual Product Reviews (APRs) through report compilation and review.Assure the use of operational excellence tools in quality procedures and processes and Drive continuous improvement initiatives which positively impact process performance and product quality throughout the product lifecycle and provide assurance of continued suitability and capability of processes through Lean methodology and QRM Principles.Through Key Quality Performance Indicator (KPI) Dashboard, monitor and report Site quality systems performance.Provide support with site data integrity assessments and actions, as well as computer system validation (CSV) plans and execution.Assist in mock recall activities for the site.Provide support in maintaining the Food Safety Plan for the manufacturing site.Other duties as assigned by Quality Management.EDUCATION AND EXPERIENCE:BS degree in a scientific field is required.A minimum of 2 years related experience preferably in an FDA regulated industry.Requires approximately 10% domestic travel and occasional international travel.Must possess strong oral and written communication skills and the ability to work independently.Must have a strong understanding of GMP and global regulatory standards.CQA certification, Lean Six Sigma Qualification, PCQI desired.TECHNICAL SKILLS REQUIREMENTS:Fluency in quality operations, systems and regulatory compliance.Demonstrated written communication skills, as well as experience with presenting to leadership teams.Strong interpersonal and communication skills; ability to communicate across all levels of the organization.May contact vendors and/or external customers for administrative and technical information.Excellent attention to detail and strong time management skills.PC literate with the following applications: MS Excel, Word, Power Point.Ability to manage multiple projects simultaneously and prioritize work, goals and tasks in accordance with division and corporate objectives.Driven / Passionate about Quality performance and delivering results.Fluent in English (written and spoken).Inspires Continuous Improvement and Breakthrough Thinking – utilizing problem solving tools such as Lean and Six Sigma.PHYSICAL REQUIREMENTS:The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.While performing the duties of this job, the employee is regularly exposed to a laboratory, office and/or manufacturing setting. Incumbent must be able to access all areas of the facility and is required to utilize certain Personal Protective Equipment, including but not limited to, hard hats, safety (“steel-toed”) shoes, eye protection, gloves, and protective clothing.
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