Senior Specialist, Quality LIMS Administration

Strides Pharma Inc • Chestnut Ridge, NY

111d

About The Position

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.

Requirements

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

Nice To Haves

• 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.

Responsibilities

• Prepares crystal reports.
• Creates or approves static data entries.
• Adds/modifies calculations, workflows, and schemas as necessary.
• Codes LIMS system to customize software platform.
• Integrates and customizes software with laboratory instrumentation.
• Responsible for instrument integration.
• Builds Crystal Reports.
• Assesses change controls as they pertain to LIMS requirements.
• Builds/Configures Electronic Laboratory Notebooks.
• Participates in cross-site implementation of new LIMS features and enhancements.
• Coordinates roll-out of additional LIMS phases.
• Assists in Project Planning and Budget Spending.
• Performs periodic audits on the system, collates and presents the results of the audit to senior management, as required.
• Develops training modules and provides user training as necessary.
• Interacts with laboratory personnel to ensure necessary developments are present and functioning, as necessary.
• Interfaces with IT department on global LIMS issues.
• Follows EH&S procedures to ensure a safe work environment.
• Performs other LIMS-related responsibilities as required by management.

Benefits

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

What This Job Offers

• Career Level: Senior
• Education Level: Bachelor's degree