Sr. Quality Systems IT Administrator
$108,000–$118,000 year
On-siteWoodstock, Illinois, United States
Woodstock, Illinois, United StatesOn-siteFull Time$108,000–$118,000 yearSenior LevelMedium
Full TimeSenior LevelMedium
Job Summary
Configure, develop, install, deploy, and maintain assigned quality and laboratory applications, including MasterControl, LabX, Empower, and NuGenesis. Monitor system health via logs and alerts, troubleshoot application issues, and manage user access, audit trails, and backup procedures for GxP-compliant environments. Serve as the primary technical contact for server and system changes impacting quality operations, coordinate vendor relationships, and support the full computerized system validation lifecycle. Manage risk to product quality, maintain application documentation, and participate in internal and external regulatory audits.
Required Qualifications
- Bachelor's degree in Information Technology, Chemistry, Engineering, or a related discipline
- 5–7 years of Quality data systems administration and/or IT experience
- minimum of 5 years in a cGMP environment
- pharmaceutical or related industry
- Functional and technical knowledge of systems such as Waters Empower, Waters NuGenesis, LabX, Novatek LIMS, and MasterControl
- knowledge of laboratory instruments/processes such as HPLCs, UV, and titrators
- Experience with CSV, GAMP, data integrity, 21 CFR Part 11 compliant systems, and regulatory/customer audits
- Working familiarity with server operating systems, server hardware, and virtualized (VM) environments
- knowledge of TCP/IP
- Strong understanding of SQL databases, queries, and reporting solutions
- Knowledge of current cGMP, FDA, and other regulatory requirements
- SOP writing and/or training experience
- Strong ability to analyze user requirements and build/source application-based solutions to specification, including implementation and systems integration between applications
- Thorough understanding of server operating systems, SQL, Windows (7 through 11), web browsers (Edge, Firefox, Chrome), Office 365, Teams, assigned applications, and relevant development and administrative tools
- basic understanding of the network and cybersecurity environment
- Self-motivated and able to work with minimal supervision, consistently delivering quality work within established timelines and procedures while multi-tasking and meeting deadlines
- Strong strategic and analytical thinking, problem solving, and decision-making, with exceptional planning and organizational skills
- Communicates clearly and concisely, both orally and in writing, and presents effectively to individuals and groups; demonstrated ability to read, write, and speak clear English
- Demonstrated ability to author technical documentation for software-controlled and data acquisition/management systems, including plans, requirements, specifications, protocols, test cases, and summary reports
- Establishes and maintains cooperative working relationships across cross-functional teams in a fast-paced, dynamic environment
- Remains current in all aspects of cGxPs, SOPs, methods, and protocols
- Ability to stand, sit, walk, climb a ladder, access all areas of the facility, use basic office equipment such as a personal computer and copier, and communicate via telephone regularly during the course of work
- Occasional lifting and/or moving of up to 30 pounds
- Must be available for technical support remotely and/or onsite outside of normal office hours
Desired Qualifications
- Master's degree
- pharmaceutical or related industry
- knowledge of laboratory instruments/processes such as HPLCs, UV, and titrators
- knowledge of TCP/IP
- SOP writing and/or training experience
- Follows trends and changes in the application administration and IT field, proactively recommending improvements and willingly learning and adopting new technologies
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