QTSS Administrator, I or II

About the Company

Ocular Therapeutix, Inc. (NASDAQ:OCUL) is a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary bioresorbable hydrogel-based formulation technology, ELUTYX™. Ocular Therapeutix has built a robust product pipeline of drug delivery solutions developed to reduce the complexity and burden of the current standard of care and position itself as a leader in the ophthalmic space. The company fosters a strong culture where employees can flourish and achieve their career goals, encouraging out-of-the-box thinking, cross-functional collaboration, and creativity at its headquarters in Bedford, MA.

About the Role

The Quality Technology Systems and Solutions (QTSS) Administrator Level I/II is responsible for the administration of laboratory and quality control software systems in a GxP-compliant environment. This onsite position reports directly to the Sr. Manager, QTSS.

Responsibilities

• Assists with maintenance and development of a robust LabWare LIMS system, including:
  • Creates and manages master data to support existing/new system functionalities
  • Supports Change Controls for Quality Computer Systems Updates
  • Develops and maintains system documentation including SOPs and Work Instructions
  • Assists with managing system updates, change controls, and maintenance activities
• User access and database administration of Empower 3 and various other analytical test equipment software, including OMNIC, Tiamo, DataPro2, MasterSizer 3000, Keyence Vision, and Instron Bluehill
• Assists with implementation of new Quality Control (QC) Software systems
• Supports Computer Systems Validation as needed
• Builds and maintains strong relationships and collaborates closely with other departments interfacing with Quality Systems, including QC Raw Materials, QC Commercial, QC Analytical, QC Stability, QC Micro, IT, and Validations
• Performs other duties as assigned

Requirements

• Degree in chemistry or related life sciences field preferred
• 2–5 years of experience in a scientific field/laboratory environment with some IT experience preferred
• Familiarity with LabWare LIMS or similar systems and QC Laboratory systems
• Knowledge of Computer System Validation and 21 CFR Part 11 compliance requirements preferred
• Empower CDS experience a plus
• Strong communication and interpersonal skills; ability to work closely with multiple departments such as QC, IT, Validation, and QA

Pay

Salary Range: $62,000 USD – $68,000 USD