QA Computer Systems Admin

Salary: $79,000

Job Summary:

We are seeking a QC Systems Administrator to help maintain LIMS, Empower, and other QC systems in compliance with 21 CFR requirements. This role includes daily system maintenance, account management, troubleshooting, and training. Additionally, you will provide quality support for on-site computer systems, including risk assessments, qualification documentation, data integrity, change control assessments, investigations, deviations, CAPA, and periodic reviews of computer system validations.

This position reports to the QA Computer System Administrator Manager at the designated site.

Key Responsibilities:

Administer user accounts, data groups, and permissions within LIMS, Empower, and other QC systems.
Troubleshoot cross-instance configurations and inbound/outbound LIMS communications with enterprise business systems.
Review and update operational and administrative SOPs for software systems.
Provide and conduct training on LIMS for system users.
Support activities related to new instrument installations that require communication with LIMS and Empower.
Assist with validations and documentation for new functionalities and system upgrades.
Ensure data integrity by performing assessments, periodic reviews, and disaster recovery planning per FDA guidelines and company SOPs.
Provide after-hours remote support to analysts for troubleshooting system issues.
Monitor and control SQL LIMS Database and other QC instruments.
Serve as a technical SME for authoring and reviewing Data Integrity Assessments, Risk Assessments, and Remediation Plans.
Provide regulatory and compliance guidance for computer system qualification and validation activities.
Review and approve validation documents and quality system records such as deviations, CAPA, and change controls.
Participate in root cause analysis and corrective action planning for investigations.
Conduct and review periodic qualification and validation reviews to ensure continued compliance.
Collaborate with IT, Automation, Validation, and Manufacturing teams to support QA decisions.
Represent QA Systems during audits and regulatory inspections.
Provide technical problem-solving in laboratory instrumentation and data integrity.
Communicate and coordinate activities with operations, QA, engineering, maintenance, and global teams.

Required Qualifications:

Bachelor’s Degree in Computer Science, Engineering, or a related technical field.
2+ years of experience in a related role.
3 years of experience in a GMP-regulated environment.
Knowledge of SQL and database management.
Experience with GMP-regulated environments and computerized/automation platforms (LIMS, DeltaV, Honeywell, Rockwell PLC, Siemens XFP).
Familiarity with ISA88 Batch Control.
2+ years of experience in laboratory software administration, including SQL*LIMS, LabWare, MODA, Empower, and QC instruments.
Strong understanding of 21 CFR requirements for laboratory instrumentation and data integrity.
Proficiency in Microsoft Word, Excel, PowerPoint, and Access.
Strong problem-solving skills and ability to read/follow detailed instructions.
Ability to train others effectively.
Availability for remote troubleshooting support outside business hours as needed.
Ability to work in a team-oriented environment across different levels and departments.
Knowledge of industry guidelines (ISPE, PDA) and global regulations (FDA, ICH, ISO, EU).

Preferred Qualifications:

Experience with document tagging, compliance monitoring, and regulatory documentation.
Familiarity with software validation and system lifecycle management.
Strong organizational and communication skills.

This role offers an exciting opportunity to support critical quality systems while ensuring compliance and efficiency across various QC platforms. If you have a passion for technical problem-solving and regulatory compliance, this position is an excellent fit.

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