Senior Specialist, Quality LIMS Administration

Job Description

Job Description

Job Title - Senior Quality Specialist, LIMS Administration

Job Summary –

The Senior Quality Specialist is responsible for the administration, analysis, and maintenance of the LIMS from the Quality IT perspective. Administers system functions (such as maintaining user lists, creating and approving static data entry, etc.), and performs audits of the system, collates and presents audit findings to senior management, interfaces with IT for more global LIMS issues, and configures LIMS-specific scripting language calculations, based on products and tests performed, workflows, and schemas to continually meet the needs of the QC Laboratories.

The Senior Quality Developer works closely with the various Quality Control laboratories and Quality Assurance to ensure compliance with CFR and GMP requirements.

Responsible for the development of modules (such as solutions inventory, reagents inventory, and stock standards) for further configuration of the LIMS, including customization of the software platform and electronic laboratory notebooks (ELNs), and coordination of the module rollout. Integrates laboratory instrumentation with the LIMS and creates customized Crystal Reports. Plans, develops, and delivers laboratory training modules for additional LIMS phases, as necessary.

Scope of Authority -

The incumbent in this position is specifically to focus on Quality development needs for LIMS, Empower, Laboratory Standalone systems, or other related development project. Issues related to QC Laboratory implementation of the LIMS are within the scope of this position. Supports the Generics Business.

Key Accountabilities & Responsibilities

Data Entry & Maintenance

• Prepares crystal reports.
• Creates or approves static data entries.
• Adds/modifies calculations, workflows, and schemas as necessary.

Configuration/Customization

• Codes LIMS system to customize software platform
• Integrates and customizes software with laboratory instrumentation
• Responsible for instrument integration
• Builds Crystal Reports
• Assess change controls as they pertain to LIMS requirements.
• Builds/Configure Electronic Laboratory Notebooks

New Phases

• Participate in cross-site implementation of new LIMS features and enhancements
• Coordinates roll-out of additional LIMS phases
• Assists in Project Planning and Budget Spending

Audit

• Performs periodic audits on the system, collates and presents the results of the audit to senior management, as required

Training

• Develop training modules and provide user training as necessary

End-User Satisfaction

• Interact with laboratory personnel to ensure necessary developments are present and functioning, as necessary.

Collaboration

• Interface with IT department on global LIMS issues

Safety

• Follows EH&S procedures to ensure a safe work environment.

Other

• Performs other LIMS-related responsibilities as required by management.

Education & Experience

• Bachelor’s degree in life science, physical science, or technology field with 5+ years’ laboratory experience performing development functions for a GMP laboratory
• 3+ years’ experience within software development
• Worked within a regulated environment (Pharmaceuticals, Medical Devices, Biotech or other regulated field)

Knowledge

• Knowledge of 21 CFR Part 11
• Strong knowledge of Computer System Validation techniques and practices
• Company SOPs applicable to job
• Thorough knowledge of general routine laboratory operations and workflow, with the ability to integrate those processes into an electronic workflow
• Strong understanding of Company SOPs applicable to job
• GMP Knowledge of FDA regulations, primarily GMP regulations
• Thorough knowledge of general routine laboratory operations and workflow, with the ability to integrate those processes into an electronic workflow.
• In-depth knowledge of Crystal Reports, SQL programming, and SSL scripts or other varying scripting languages such as JavaScript, SQL, Java

Skills & Abilities

• Advanced computer skills
• Strong attention to detail. Highly productive, able to manage time and prioritize tasks to meet timelines.
• Strong interpersonal and communication skills; confident presenter, clear, concise technical writer.
• Able to interact with various departments and levels.
• Customer focused.
• Troubleshooting and critical thinking skills. Able to define problems, collect data, establish facts and draw conclusions.

Physical Requirements

• Ability to lift 15 lbs.
• Ability to walk across plant/laboratory.
• Travel up to 20% of the time may be required.