International SAP Projects Junior LIMS admin | 5+ years | @ Rocky Mount , NC
Hi Partners, Good Morning. Please help me out to submit suitable profile . Please connect with me at *Naseer Bhat* Desk : 609-853-0818 Ext: 2184 naseer.ah...@nityo.com *Jr Lab Admin * Are you looking for a change? Do you want to collaborate with some of the best talent in the industry? Are you ready to join a company whose passion is to provide its clients with operational excellence and helping them optimize their needs that really make a difference to enterprises, the community and the world? Then you are the one that we are looking for to be part of our growing *Business IT Services (BITS) practice*, positioned byGartner as a leader in its first-ever Magic Quadrant for Oracle Application Management Service Providers, Worldwide. *Wanted: Global Innovators To Help Us Build Tomorrow’s Enterprise* In the role of Technology Consultant, you will be a technology professional adding value to a gamut of Software Development lifecycle stages. You will create detailed design artifacts like program specifications, test plans; and independently develop and review code and contribute to the go-live plan. You will have the opportunity to collaborate with some of the best talent in the industry to create innovative high quality and defect-free solutions to meet our clients’ business needs.You will be part of a learning culture, where teamwork and collaboration are encouraged, excellence is rewarded, and diversity is respected and valued Location for this position is Rocky Mount, NC *Qualifications Basic* • Bachelor’s degree or foreign equivalent from an accredited institution or three years of progressive experience in the specialty in lieu of every year of education. • Clinical background/ knowledge and work experience in provider set up will be an extra advantage. • At least 4-5 years of experience is required in healthcare provider IT operations, consultation and diagnostic area. • 2 years related LIMS experience: configuration, validation, implementation, and system admin. • 2 years’ experience in a GMP environment (preferably as a chemist or microbiologist in a pharmaceutical lab). 2 to 3 years in computer system validation and analytical instrumentation testing. *Primary Skills* • Experience in Empower, NuGenesis, Chromeleon, or WinKQCL is desired. Environmental Monitoring or program design experience desired • Working knowledge or biology, chemistry, life sciences with strong skills in computer system management. • Knowledge of cGMPs and regulatory requirements around computer systems including 21 CFR Part 11, GAMP5, and applicable ISO standards. • Strong analytical skills and balanced decision making; must have the ability to formulate appropriate system queries. • Possess good communication skills and attention to detail. • Knowledge of risk and impact assessment tools strongly desired. • Knowledge of root cause analysis tools and investigational skills preferred. *Additional Responsibilities* • Provides technical support for laboratory quality system to the quality control laboratories, Biological Quality (BQ), Chemical Quality (CQ), and Supplier Quality (SQ); Ensure that the systems comply with all relevant regulatory standards including assessing systems for CFR Part 11 compliance/ISO Part 11 compliance. • Diagnostic support for application. Management and timely resolution of technical incidents through the standard incident and problem management process; Responsible for elevation of incidents to 2nd tier support and summarization and reporting of incidents to system owners and effected users when required. • Ensure site on-time implementation of laboratory quality system through support of requirements definition, functional design, management of master data configuration, data migration, reporting design, system validation, SOP generation, development, and end-user training. • Provides a key role in system governance. Review and management of system change control processes, including establishing or revising user requirements, design requirements, functional specification, design specifications, or qualification protocols. • Define and manage process efficiency and continuous improvement projects for laboratory systems. • Technical writing for system validation protocols, standard operating procedures, and other technical documents in support of validation/operations. • Support business in creation, validation, and maintenance of reports, calculations, and queries within quality systems. • Support system periodic review, security review, and audit trail review activities. • Support audits and inspections to provide data and information on request, provide ad hoc support to other department to ensure compliance with all regulatory standards. -- You received this
International SAP Projects Junior LIMS admin | 5+ years | @ Rocky Mount , NC
Hi Partners, Good Morning. Please help me out to submit suitable profile . Please connect with me at *Naseer Bhat* Desk : 609-853-0818 Ext: 2184 naseer.ah...@nityo.com *Jr Lab Admin * Are you looking for a change? Do you want to collaborate with some of the best talent in the industry? Are you ready to join a company whose passion is to provide its clients with operational excellence and helping them optimize their needs that really make a difference to enterprises, the community and the world? Then you are the one that we are looking for to be part of our growing *Business IT Services (BITS) practice*, positioned byGartner as a leader in its first-ever Magic Quadrant for Oracle Application Management Service Providers, Worldwide. *Wanted: Global Innovators To Help Us Build Tomorrow’s Enterprise* In the role of Technology Consultant, you will be a technology professional adding value to a gamut of Software Development lifecycle stages. You will create detailed design artifacts like program specifications, test plans; and independently develop and review code and contribute to the go-live plan. You will have the opportunity to collaborate with some of the best talent in the industry to create innovative high quality and defect-free solutions to meet our clients’ business needs.You will be part of a learning culture, where teamwork and collaboration are encouraged, excellence is rewarded, and diversity is respected and valued Location for this position is Rocky Mount, NC *Qualifications Basic* • Bachelor’s degree or foreign equivalent from an accredited institution or three years of progressive experience in the specialty in lieu of every year of education. • Clinical background/ knowledge and work experience in provider set up will be an extra advantage. • At least 4-5 years of experience is required in healthcare provider IT operations, consultation and diagnostic area. • 2 years related LIMS experience: configuration, validation, implementation, and system admin. • 2 years’ experience in a GMP environment (preferably as a chemist or microbiologist in a pharmaceutical lab). 2 to 3 years in computer system validation and analytical instrumentation testing. *Primary Skills* • Experience in Empower, NuGenesis, Chromeleon, or WinKQCL is desired. Environmental Monitoring or program design experience desired • Working knowledge or biology, chemistry, life sciences with strong skills in computer system management. • Knowledge of cGMPs and regulatory requirements around computer systems including 21 CFR Part 11, GAMP5, and applicable ISO standards. • Strong analytical skills and balanced decision making; must have the ability to formulate appropriate system queries. • Possess good communication skills and attention to detail. • Knowledge of risk and impact assessment tools strongly desired. • Knowledge of root cause analysis tools and investigational skills preferred. *Additional Responsibilities* • Provides technical support for laboratory quality system to the quality control laboratories, Biological Quality (BQ), Chemical Quality (CQ), and Supplier Quality (SQ); Ensure that the systems comply with all relevant regulatory standards including assessing systems for CFR Part 11 compliance/ISO Part 11 compliance. • Diagnostic support for application. Management and timely resolution of technical incidents through the standard incident and problem management process; Responsible for elevation of incidents to 2nd tier support and summarization and reporting of incidents to system owners and effected users when required. • Ensure site on-time implementation of laboratory quality system through support of requirements definition, functional design, management of master data configuration, data migration, reporting design, system validation, SOP generation, development, and end-user training. • Provides a key role in system governance. Review and management of system change control processes, including establishing or revising user requirements, design requirements, functional specification, design specifications, or qualification protocols. • Define and manage process efficiency and continuous improvement projects for laboratory systems. • Technical writing for system validation protocols, standard operating procedures, and other technical documents in support of validation/operations. • Support business in creation, validation, and maintenance of reports, calculations, and queries within quality systems. • Support system periodic review, security review, and audit trail review activities. • Support audits and inspections to provide data and information on request, provide ad hoc support to other department to ensure compliance with all regulatory standards. -- You received this
