System Administrator - GMP Laboratory

Company: Pace Analytical Services, LLC
Location: Saint Paul
Posted on: August 6, 2022

Job Description:

Summary:
The System Administrator - GMP Laboratory is responsible for participating in systems related to generation of GMP documents and records for FDA regulated environment. Responsibilities will involve interacting with vendors and local IT support functions to configure, install, qualify, and validate the systems, assist with installing and qualifying network IT systems such as physical and virtual servers, as well as installing and validating laboratory IT systems such as ELN, EDMS, LIMS, and other various lab software. The role will also be responsible for monitoring, execution, maintenance, and continuous improvement of the IT Systems with an emphasis on change control, validation/qualification, continuous improvement, especially in regard to data integrity. This role will serve a business representative for laboratory IT systems and will be responsible for mentoring, educating peers on the use of lab systems, supporting audits.Essential Functions:
This class specification lists the major duties and requirements of the job and is not all-inclusive. Incumbent(s) may be expected to perform job-related duties other than those contained in this document and may be required to have specific job-related knowledge and skills.

• Participate in GMP validation activities including the execution of IQ/OQ/PQ testing; assist with creation of test scripts as required. Perform integration and system level tests and execute any necessary supporting documentation.
  
• Support the establishment and maintenance of the validated state of software-based computerized systems in use in the laboratory.
• Apply cGMP principles by following internal SOPs and regulatory requirements.
• Help lead site deployment and upgrades of Laboratory IT systems such as Empower, UNIFI, MassHunter, ELN, and LIMS.
• Help to maintain and administer internal Life Sciences Help Desk, Internal Life Sciences Network, network backups, and Active Directory (including group policies).
• Provide oversight and support continuous improvement of quality systems as they relate to the laboratory.
• Apply knowledge of quality principles, CGMP, and laboratory systems towards the development and execution of local procedures and practices.
• Perform and mentor others in change control, deviations/modifications, investigations, root cause, and activity planning.
• Participate in Server (VMware, virtual and physical) setup (inventory, qualification, changes, maintenance, repairs).
• Provide support during systems implementation and configuration to ensure the solutions will meet business needs while adhering to IT and Quality policies and procedures and compliance standards.
• Diagnose, troubleshoot, and resolve hardware, software, or other network and system problems, and replace defective components when necessary.
• Assist in the qualification of internal networks.
• Contribute to the efficiency and effectiveness of the department's service to its customers by offering suggestions and directing or participating as an active member of a work team
• Promote and support the overall mission of Pace Analytical by demonstrating courteous and cooperative behavior when interacting with customers and staff; acts in a manner that promotes a harmonious and effective workplace environment.
  
  Qualifications:To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.
  
  Education and Experience:
  Bachelor's Degree with 1 years of relevant experience or equivalent.Or Associate degree with 3 years of relevant experience or equivalent.
  
  Preferred Knowledge and Skills
  Preferred Knowledge:
• Microsoft Active Directory
• Server/VMware/Virtualization
• Data backup and restore
• Microsoft operating systems and software installation and maintenance, including servers and workstations
• Standard personal computer system hardware and business application software operating capabilities and limitations
• Knowledge of managing and configuring Switch/Routers/Wi-Fi access points
• Understanding of GAMP 5, 21 CFR Part 11 and Computer System Validation / Computer Software Assurance
• Experience administrating LIMS (Preferred not required).
• Ability to communicate with staff, coworkers, and customers to ensure safe, effective, and appropriate operations.
  Preferred Skills:
• Maintaining accurate records of work performed.
• Preparing clear and concise documentation, user instructions, reports, correspondence, and other written materials.
• Working without close supervision in standard work situations.
• Multi-tasking between project and event driven work.
• Using initiative and independent judgment within established procedural guidelines.
• Contributing effectively to the accomplishment of team or work unit goals, objectives, and activities.
• Establishing and maintaining effective working relationships with a variety of individuals contacted in the course of the work.Physical/Mental Requirements:The physical demands described herein 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.Mobility to work in an office setting, use standard office equipment and ability/stamina to stand/sit for extended periods of time; ability to wear appropriate PPE; ability to lift/push/pull/carry up to 40 pounds; ability to crouch/bend/twist/reach; must be able to perform activities with repetitive motions; vision to read printed materials and computer screens for extended periods of time; and hearing and speech to communicate in person or over the telephone.
  
  Working Environment:Work is performed in an office/laboratory setting. Work may be subject to exposure to electrical shocks and chemicals.OFCCP Statement Pace Analytical is an Equal Opportunity Employer and will not discriminate against any applicant for employment on the basis of race, age, religion, sex, veterans, and individuals with disabilities, sexual orientation, or gender identity.
  
  #STAR
  Monday through Friday first shift hours. Time to time request to come in early, stay late, and occasional weekend work as needed.

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