Naseer Bhat
Desk : 609-853-0818 Ext: 2184
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.
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