QA Computer System Admin II

Are you passionate about ensuring the reliability and compliance of quality control systems in a regulated environment? As a Quality Systems Administrator, you will play a key role in maintaining and supporting laboratory information management systems (LIMS), Empower, and other quality control (QC) systems. Your responsibilities will include system administration, troubleshooting, training, and compliance with industry regulations. This role reports to the QA Computer System Administrator Manager.

What You'll Do

Manage data groups, user access, and permissions within LIMS, Empower, and other QC systems.

Support troubleshooting for system configurations across multiple locations and facilitate communication between LIMS and external systems.

Review, update, and maintain software operational and administrative procedures.

Provide training on LIMS to support system users.

Assist in the integration and validation of new laboratory instruments that interact with LIMS and Empower.

Support validation activities and documentation for system updates and new functionalities.

Ensure data integrity through regular assessments, periodic reviews, and disaster recovery planning in compliance with FDA guidelines and company policies.

Provide after-hours remote support for troubleshooting issues.

Monitor and control SQL LIMS databases and other QC instruments.

Act as a subject matter expert for authoring and reviewing data integrity assessments, risk evaluations, and remediation plans.

Offer regulatory and compliance guidance for computer system validation, qualification, and commissioning activities.

Review and approve validation documents and quality system records such as deviations, CAPAs, and change control requests.

Participate in root cause investigations and implement corrective actions.

Collaborate with IT, automation, validation, and manufacturing teams to maintain compliance and enhance system functionality.

Represent the QA Systems team during audits and regulatory inspections.

What You Bring

Bachelor's degree in Computer Science, Engineering, or a related technical field.

2+ years of experience in quality systems administration, preferably in a GMP-regulated environment.

Strong understanding of SQL databases and experience with laboratory software administration (SQL*LIMS, LabWare, MODA, Empower, and other QC instruments).

Technical knowledge of automation platforms such as LIMS, DeltaV, Honeywell, Rockwell PLC, Siemens XFP, and ISA88 Batch Control.

Familiarity with regulatory guidelines (ISPE, PDA, FDA, ICH, ISO, EU) and industry best practices.

Ability to analyze complex technical issues and provide effective solutions.

Proficiency in Microsoft Word, Excel, PowerPoint, and Access.

Strong verbal and written communication skills, with the ability to train and support users at all levels.

Availability to provide remote support outside of normal business hours when needed.

Ability to work effectively in a team-oriented environment.

Work Environment & Requirements

May require wearing personal protective equipment (PPE) such as safety shoes, glasses, gloves, and lab coats.

Must comply with cleanroom requirements, including the removal of makeup, jewelry, and contact lenses when necessary.

Work may involve exposure to cold, wet environments and handling chemicals such as alcohol, acids, and buffers.

Flexibility to work multiple shifts, including weekends or additional hours as needed.

Why Join Us?

This is an opportunity to contribute to a dynamic and regulated environment where your work ensures the safety and quality of pharmaceutical products. You'll gain experience working with cutting-edge QC systems while collaborating with talented professionals across various departments. If you're detail-oriented, passionate about quality, and eager to make an impact, we'd love to hear from you!
Employment Type: Full-Time
Salary: $ 68,000.00 107,000.00 Per Year