QTSS Administrator, I or II

Ocular Therapeutix, Inc.; Bedford (MA); On-site; USD 62,000 - 68,000; Full time

Job summary

Ocular Therapeutix, Inc. is seeking an on-site LIMS and QC software administrator in Bedford, MA. The role focuses on administering LabWare LIMS in a GxP environment, maintaining system documentation, and supporting validation and change controls across QC, IT, and QA teams.

The position reports to the Sr. Manager, QTSS and requires 2–5 years in a scientific setting with familiarity with LabWare LIMS and related QC systems. Equal opportunity employer; privacy policy applies.

Qualifications

• Degree in chemistry or related life sciences field preferred.
• 2–5 years of experience in a scientific field/laboratory 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.
• Good communication and people skills, able to work with multiple departments (QC, IT, Validation, QA).

Responsibilities

• Administers LabWare LIMS in a GxP environment; manages master data for system functionality.
• Supports Quality Computer Systems updates and change controls.
• Develops and maintains system documentation including SOPs and work instructions.
• Manages system updates, change controls and maintenance activities.
• Performs user access and database administration of Empower 3 and other analytics software (OMNIC, Tiamo, DataPro2, MasterSizer 3000, Keyence Vision, Instron Bluehill).
• Collaborates with QC, IT, Validation, QA and other departments.

Skills

LIMS administration

QC software

Documentation

Cross-functional collaboration

Communication

Education

Degree in chemistry or related life sciences

Tools

LabWare LIMS

Empower CDS

DataPro2

OMNIC

Tiamo

ECLIPSE

Keyence Vision

Job description

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 to become a leader in the ophthalmic space.

Outside of the ophthalmic realm and behind the doors of our headquarters in Bedford, MA, we strive to build a strong culture where employees can flourish and achieve their career goals. We encourage out of the box thinking, cross-functional collaboration, and creativity.

Position Summary

• Administration of Laboratory Information Management System (LIMS)
• Administration of Quality Control Software Systems, including but not limited to Empower, Tiamo, OMNIC, ECLIPSE, DataPro2, Keyence Vision Systems, etc.
• Assistance with implementation of new Quality Control (QC) Software systems.
• Supports Computer Systems Validation as needed.

This position is onsite and reports directly to the Sr. Manager, QTSS.

Principal Duties And Responsibilities Include The Following

• Assists with maintenance and development of a robust LabWare LIMS system in a GxP compliant environment, including but not limited to:
  • 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 activates
• User access and database administration of Empower 3 and various other analytical test equipment software including: OMNIC, Tiamo, DataPro2, MasterSizer 3000, Keyence Vision, Instron Bluehill and others.
• Builds and maintains strong relationships and collaborates closely with other departments which interface with Quality Systems, including QC Raw Mats, QC Commercial, QC analytical, QC Stability and QC Micro, IT, Validations, Etc.
• Other duties as assigned.

Qualification Requirements

• Degree in chemistry or related life sciences field preferred
• 2-5 to years of experience in a scientific field/laboratory environment with some knowledge of 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
• Good communication and people skills, need to work closely with multiple departments such as QC, IT, Validation, QA, etc.

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

Ocular Therapeutix is an Equal Opportunity Employer and complies with all applicable federal, state, and local laws regarding nondiscrimination. Ocular Therapeutix provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, or status as a veteran. For information on how Ocular Therapeutix collects, stores, and utilizes candidate information please see our privacy policy found at https://www.ocutx.com/privacy-policy/. For the Privacy Notice for California Job Applicants, please see CCPA Applicant Notice.