Now Hiring:

LIMS Administrative Role

Department:
Quality Control
Location:
Pomona, CA
Job Family:
Quality & Compliance
Business Unit:
DPM&S
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Company Overview

Headquartered in Pomona, California, Med-Pharmex, Inc. is among the leading developers and manufacturers of generic veterinary pharmaceutical products in the U.S.  The Company markets over 25 FDA-approved products, all manufactured in one of its three FDA-approved, Pomona-based facilities, with multiple drug delivery systems such as injectables, suspensions, oral solutions, sprays, ointments, creams, pastes, and powders.  Utilizing its expertise and experience in pharmaceutical product development in a cGMP environment, the Company’s strength lies in its ability to continually innovate and develop products with high barrier entry, successfully navigate FDA regulatory requirements, and bring quality generic drug products to the veterinary market.

Job Purpose

Play a key role in selection of vendors and systems, implementation, and maintenance of complex laboratory electronic systems. This role will lead in requirements gathering, user requirement specifications, configuration, solution design, design specifications writing, training, process improvement and support. Execute systems gap analysis, process mapping, road map creation to successful selection and implementation of new laboratory systems. Work with users extensively to identify solutions, provide user support for efficient and cost-effective operations to learn new technologies. Familiarity with lab quality processes, FDA regulatory requirements.

Key Responsibilities

  • Serve as a project leader in the implementation Caliber LIMS for QC, manufacturing, and other areas as applicable.
  • Lead gathering of user requirements, configurations, design specification and communicate with developers to ensure proper development of the Laboratory systems and other electronic systems used in GMP manufacturing.
  • Describe workflow into software requirements, execute and review validation documents
  • Set up and organize system specific processes
  • Serve as the subject matter expert (SME) on validation requirement, master data setup, reporting, equipment integration, and enterprise systems related to QC and Manufacturing.
  • Ensure Laboratory system is compliant with all relevant regulatory standards and support audits for LIMS specific topics
  • Provide end user training to operate the system
  • Support training and use of LIMS and other lab systems for each functional area
  • Author, revise, implement, and manage LIMS and other lab systems related procedures for administrator and users
  • Create and maintain data configurations for users and integration of the instruments to LIMS
  • Partner with IT and external vendors to manage implementation, enhancements, incident investigation, system impact assessments and change controls
  • Job Title LIMS Administrative Role Business Unit DPM&S
  • Job Family Quality & Compliance Department QC & Compliance Reports
  • To QC Compliance Manager Location Pomona, CA.
  • Lead, develop, and manage lab systems related change controls, NC, CAPAs
  • Implement best practices on LIMS development, master data, reporting, and configurations
  • Track and troubleshoot lab systems support program issues
  • Collaborate closely with IT group and stakeholders in developing system infrastructure and database requirements
  • Conduct risk assessments and champion continuous improvement
  • Work directly with LIMS software partner for the design, configuration, testing and implementation of a cloud-based LIMS software. Following implementation, monitor vendor progress to optimize operational capabilities and uptime.
  • Develop and validate LIMS system interfaces and other external applications as needed
  • Facilitate lab instrument integration with LIMS software
  • Work directly with Lab Managers to develop and present LIMS reports as needed
  • Serve as the laboratory’s LIMS system administrator and provide end user training to personnel
  • Troubleshoot issues with the system and interact with LIMS provider when necessary to develop solutions
  • Support the development and validation of an overall LIMS strategy to ensure the program is scalable and in alignment with business initiatives

Competencies

Commercial and Business AcumenEngagement
Project ManagementProblem Solving
Relationship ManagementCustomer Service
Results FocussedProduct and Technical Knowledge

Person Specification

EssentialDesirable
Behaviour and ValuesCommitted to delivering excellence
Enthusiastic and results driven
Able to take calculated risks
Honest with a high level of integrity
Team player
Willing and able to go the extra mile
QualificationsMinimum of 6 years of work experience with LIMS and other laboratory system in the Pharmaceutical, Life Sciences industry with GXP. Experience with Caliber LIMS preferred
Knowledge and ExperienceLIMS Certification preferred

Med-Pharmex is an equal opportunity employer and prohibits discrimination and harassment of any type and affords equal employment opportunities to employees and applicants without regard to race, color, religion, sex (including pregnancy, childbirth and related medical conditions), sexual orientation, gender (including gender identity and gender expression), medical condition, genetic information, marital status, national origin, mental and physical disability, military and veteran status, or any other characteristic protected by law.

Application for
LIMS Administrative Role

Upload Resume/CV & Cover Letter. If separate documents, select all at same time. Accepted Files types: .pdf, .doc, .docx, .zip  Max size 6MB

Med-Pharmex, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

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