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Validation manager • durham nc
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Reporting directly to the division Sterilization Quality Engineer Lead, this position involves support for the sterilization operations and product sterility assurance program.This position provide...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
Qualification Scientist For Qc Laboratory Equipment.Validation & Engineering Group, Inc.V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
We are looking for a Restaurant Manager to help manage our Dunkin' Team!.A Restaurant Manager is responsible for providing strong, positive leadership to his / her team to deliver great and friendly ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
Flexible scheduling with a side of always feeling valued.A job at McDonald's offers a job combo that fits YOU.Employee discounts and free meals.
Paid sick leave and / or paid time off.Tuition reimburs...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
Supports manufacturing and packaging departments through capital projects and continuous improvement initiatives.Leads critical capital projects, supports new product launches, and represents the E...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
Overall responsibility for operating the store at maximum sales and profit with the Company policies and procedures.Store Manager is expected to work the number of hours necessary to successfully o...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
Overall responsibility for operating the store at maximum sales and profit with the company policies and procedures.Store Manager is expected to work the number of hours necessary to successfully o...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
The operations coordinator will provide overall administrative management and coordination of a variety of business-related functions, such as finance, budget, personnel transactions, space, and fa...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
A company is looking for a Senior Analyst, Model Validation.Key Responsibilities Validate the performance and controls of quantitative models Identify risks and provide recommendations to mitiga...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
You'll be responsible for keeping the restaurant exceptionally clean and well-run.She / He will assist the Assistant General Manager and General Manager in the day-to-day fast food restaurant operati...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
City Wide is seeking a Night Manager to oversee service providers, and work with the account manager on resolving customer issues.
As a City Wide Night Manager, you will develop and maintain product...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
Validation / Process Engineer Date : XXX Site : Durham, NC FLSA Status (US Only) : Exempt / Non-Exempt Department : Manufacturing Reporting To : (Title) Position Summary Medpharm seeks a talented Vali...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
Playa Bowls is New Jerseys Original Acai Shop founded in 2014, and our mission is to serve the highest quality, innovative products to support healthier lifestyles and inspire a world of fun, excit...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
Jason's Deli is a family-owned business that has been enjoyed by its communities since 1976.At Jason's Deli, we work hard to ensure that our employees are rewarded with advancement, recognition, an...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
CQV PQ Lead - Pharmaceuticals - North Carolina - 12-Month Contract .Our client, a global Pharmaceutical manufacturing organization are looking for a talented CQV PQ Lead to join their expanding tea...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
Our client, a leading technology solutions provider, is seeking a CCNA Network Solutions Validation Engineer to join their team.
As a CCNA Network Solutions Validation Engineer, you will be part of ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
Length of Contract : months with strong likelihood to extend additional months.Validates software for Laboratory and Manufacturing software and instruments.
Understands how aspects of data integrity,...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30)
If you’re an experienced restaurant assistant manager or shift manager, think about a career with Pizza Hut! You know who you are - a natural leader, you love putting together a winning...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
The little things are the big things in our kitchens.Each of our menu items are made in small batches to ensure the premium freshness of our flavors.
Our on-premise butcher shop allows our team to h...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
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Validation Engineer
Katalyst HealthCares & Life SciencesDurham, NCjob_description.job_card.30_days_ago
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job_description.job_card.job_descriptionThis position interacts with multiple functional groups within manufacturing and sterilization networks. Supports product sterility assurance and compliance across multiple sites within the Life Sciences division. Serves as the quality representative to support multiple projects within the division. Schedules / coordinates / performs assigned projects, compiles test data, writes summary reports and final reports. Provides validation support including master validation planning, change controls, protocol development, review and approvals, IQ / OQ / PQ execution / support, assist with FMEAs and control plans, assist with documentation in electronic document management system. Lead and support activities related to product changes impacting sterilization equipment / processes and the associated laboratory / functional testing required as part of the validations. Facilitate / support investigations for product and process discrepancies and propose corrective actions to process deviations and customer complaints. Assist with the investigation of Corrective & Preventive Actions (CAPA), providing solutions where possible. Create or modify user documentations that fit the business needs and maintain compliance to the regulatory requirements of the FDA and ISO standards. Ensures compliance to regulatory requirements related to product sterility assurance including annual product reviews, environmental controls, bioburden testing, dose audit maintenance and sterility testing. Serve as a resource for performing internal audits to ensure quality system compliance. Drive improvements to deliver on key quality goals and metrics. Able to react to change and perform other duties as assigned. Bachelor's Degree required, prefer program in Sciences or Engineering. Minimum of + years of quality engineering experience in a highly regulated industry; strongly prefer medical device or pharmaceutical. Direct experience in sterility assurance or product sterilization a plus. Strong knowledge of the regulatory and quality system requirements CFR Parts , / , ISO , ISO , ISO and ISO . Leadership ability to coordinate projects at multiple locations in a multi-functional team environment. Working knowledge of databases and spreadsheet applications to perform necessary tasks for preparing required data analysis, reports, documents and general communication. Knowledge of manufacturing processes and relevant statistical methods for quality assurance. Good understanding of continuous improvement methodologies, including lean, six sigma, statistical applications and validation. Must have proficiency using Microsoft Office, Project, Outlook, and software applications. Demonstrated technical writing skills. Experience with sterilization processes highly preferred. ASQ Certified Quality Engineer desired. Minitab software proficiency, desired. Ability to work independently with strong time management and prioritization skills to handle multiple assignments and interact with project teams. Ability to make decisions regarding product disposition and corrective and preventive action effectiveness. Comfortable in giving direction to accomplish work being executed.
Job Description :
- Reporting directly to the division Sterilization Quality Engineer Lead, this position involves support for the sterilization operations and product sterility assurance program.
- This position provides quality guidance for product and process sterility, product resolution decisions, and statistical problem-solving techniques to manufacturing operations and project teams for new product introduction, process improvements, continuous improvements, and validation activities.
- This position works closely with other functions within the organization (Manufacturing, Laboratory, R&D, Quality Systems, Engineering, Procurement and Marketing) and is responsible for ensuring the sterilization requirements are met for product sterilized to ensure compliance to regulatory, customer and internal standards.
Responsibilities :
Requirements :