Principle System Administrator
Spectraforce
Westborough, Massachusetts
2 hours ago
Job Description
Title: Principle System Administrator
Location: Westborough, MA (Onsite)
Duration: 12 months (possibility of extension)
Description:
The Principle System Administrator will be responsible for defining the requirements for implementation of software systems and managing the requirements for the ongoing operations as the primary interface between Operations and IT. Some examples of this would be user management, master data configuration and role management. Primary platforms will be LIMS and EBR applications. In addition, they will be responsible for supporting data integrity efforts at the site to ensure compliance to 21CFR Part 11 for manufacturing and lab equipment.
Essential Job Responsibilities:
• Develop and maintain system configuration documentation and plan for new product, equipment, and workflows. Provide first line of troubleshooting issues for users.
• Manage the operations of systems in a validated environment and develop policies and procedures related to compliance requirements; Work with end users to develop user requirements and configuration documents and manage vendor IQ/OQ of equipment.
• Develop, revise, and review SOPs, protocols and reports and other documents to support equipment, platforms, and other computerized systems.
• Develop and provide computerized system training to new users and grant system access and ensure lab compliance with applicable cGMP regulations and SOPs, and support both internal and external audits; Collect and report metrics.
• Manage system updates, change controls and maintenance activities as relating to systems.
• Troubleshoot issues, solve problems, and assist with investigations and deviations related to software systems.
• Create/manage master data to support existing/new system functionalities.
• Ensures that the integrity and accuracy of all documents are maintained; must assess overall document compliance with protocols, SOPs, company policies, and applicable regulations.
Quantitative Dimensions:
The Principle System Administrator will be accountable for defining the requirements for implementation and management digital systems and managing the requirements for the ongoing operations. This role will work closely with the IT technical lead.
Organizational Context:
The Principle System Administrator will typically report to the Associate Director, Manufacturing Technical Support. This role is expected to Model our Core Values and to demonstrate work performance as someone who exemplifies the culture we want to create; operates with transparency; is trusted; and supports the overall mission and vision of client's Gene Therapies and the organization.
Required
• B.S. degree in biological sciences, cell biology, chemistry, or related field with 7+ years or M.S. degree with 5+ years of relevant experience in working with analytical computerized systems
• Prior laboratory hands-on experience with a variety of analytical computerized systems
• Expertise in regulations governing data integrity and computerized systems
• Experience in qualification of analytical equipment, including those with computerized systems
• Experience with electronic document management systems
• Strong interpersonal skills, highly collaborative within a multi-discipline team and contributes to a supportive and positive work environment
• Strong knowledge of GMP, SOPs and quality control processes
• Strong knowledge of quality systems and regulatory requirements
• Experience and knowledge in implementation and management of LIMS
• Experience in translating laboratory user requirements to IT implementations
• Experience with Windows OS, domains, networks and basic computing infrastructure in lab/production environment
• Good to excellent technical writing skills and verbal communication skills
• Excels in a fast-paced team environment, handles multiple tasks concurrently, and in a timely fashion
• Highly self-motivated and goal oriented
• Will support and demonstrate quality standards to ensure data of highest quality
Preferred
• Experience in a small company and high growth, fast-paced environment
• Experience working with additional electronic laboratory systems such as ERP, BMRAM, Empower, LabX.
• Experience with instrument integration/direct data capture from stand-alone COTS systems to LIMS application
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 75.00/hr.
Location: Westborough, MA (Onsite)
Duration: 12 months (possibility of extension)
Description:
The Principle System Administrator will be responsible for defining the requirements for implementation of software systems and managing the requirements for the ongoing operations as the primary interface between Operations and IT. Some examples of this would be user management, master data configuration and role management. Primary platforms will be LIMS and EBR applications. In addition, they will be responsible for supporting data integrity efforts at the site to ensure compliance to 21CFR Part 11 for manufacturing and lab equipment.
Essential Job Responsibilities:
• Develop and maintain system configuration documentation and plan for new product, equipment, and workflows. Provide first line of troubleshooting issues for users.
• Manage the operations of systems in a validated environment and develop policies and procedures related to compliance requirements; Work with end users to develop user requirements and configuration documents and manage vendor IQ/OQ of equipment.
• Develop, revise, and review SOPs, protocols and reports and other documents to support equipment, platforms, and other computerized systems.
• Develop and provide computerized system training to new users and grant system access and ensure lab compliance with applicable cGMP regulations and SOPs, and support both internal and external audits; Collect and report metrics.
• Manage system updates, change controls and maintenance activities as relating to systems.
• Troubleshoot issues, solve problems, and assist with investigations and deviations related to software systems.
• Create/manage master data to support existing/new system functionalities.
• Ensures that the integrity and accuracy of all documents are maintained; must assess overall document compliance with protocols, SOPs, company policies, and applicable regulations.
Quantitative Dimensions:
The Principle System Administrator will be accountable for defining the requirements for implementation and management digital systems and managing the requirements for the ongoing operations. This role will work closely with the IT technical lead.
Organizational Context:
The Principle System Administrator will typically report to the Associate Director, Manufacturing Technical Support. This role is expected to Model our Core Values and to demonstrate work performance as someone who exemplifies the culture we want to create; operates with transparency; is trusted; and supports the overall mission and vision of client's Gene Therapies and the organization.
Required
• B.S. degree in biological sciences, cell biology, chemistry, or related field with 7+ years or M.S. degree with 5+ years of relevant experience in working with analytical computerized systems
• Prior laboratory hands-on experience with a variety of analytical computerized systems
• Expertise in regulations governing data integrity and computerized systems
• Experience in qualification of analytical equipment, including those with computerized systems
• Experience with electronic document management systems
• Strong interpersonal skills, highly collaborative within a multi-discipline team and contributes to a supportive and positive work environment
• Strong knowledge of GMP, SOPs and quality control processes
• Strong knowledge of quality systems and regulatory requirements
• Experience and knowledge in implementation and management of LIMS
• Experience in translating laboratory user requirements to IT implementations
• Experience with Windows OS, domains, networks and basic computing infrastructure in lab/production environment
• Good to excellent technical writing skills and verbal communication skills
• Excels in a fast-paced team environment, handles multiple tasks concurrently, and in a timely fashion
• Highly self-motivated and goal oriented
• Will support and demonstrate quality standards to ensure data of highest quality
Preferred
• Experience in a small company and high growth, fast-paced environment
• Experience working with additional electronic laboratory systems such as ERP, BMRAM, Empower, LabX.
• Experience with instrument integration/direct data capture from stand-alone COTS systems to LIMS application
Applicant Notices & Disclaimers
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At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 75.00/hr.