LIMS Admin/Business Analyst 2

Technical Operations San Diego, CA


Description

About Pacira

Pacira BioSciences, Inc. is a leading provider of non-opioid pain management and regenerative health solutions dedicated to improving outcomes for health care practitioners and their patients. Our in-depth knowledge of non-opioid pain management, coupled with our passion for advancing patient care, drives our commitment to providing solutions that address unmet medical needs and improve clinical results.

Why work with us?

Rarely do you have an opportunity to do work that really matters. What drives us is our mission. What makes us successful are our people.  At Pacira, you are part of an inclusive culture that fosters collaboration, growth, and innovative thinking - a place where you can make an impact and help change the standard of care in non-opioid pain management. Be part of our movement, let’s pursue excellence together.

 

The primary roles of the position are to provide LIMS Administrator support for the LabWare or MODA software used in the QC or Micro Laboratory including user support, data management, and system configuration; the Business Analyst will directly work with clients at all levels to gather requirements and develop/implement innovative solutions to meet compliance needs for FDA requirements.

The secondary role is to provide Administrator support for LabWare or MODA and Agilent ECM/OpenLab.

 

Essential Duties & Responsibilities:

  • Oversees and implements all software  modifications to the LIMS using Software Development Life Cycle (SDLC) best practices, working in conjunction with the software validation team
  • Performs necessary IQ/OQ/PQ in conjunction with software validation team pertaining to the LIMS
  • Creates, updates, and maintains all operational procedures relevant to the LIMS and trains the departments as necessary with respect to any changes
  • Perform system analysis which includes completing requirement definitions, interfacing with business groups and providing  benefit analysis
  • Maintain LIMS knowledge, including staying current on LIMS software capabilities and availability of new functionality and updates from the software vendor
  • Point of contact for technical support; ensure accuracy and completeness of data and implement improvements; establish and maintain security and data integrity controls
  • Maintain familiarity with Micro and QC Lab industry best practices and company specific change control SOPs
  • Interface with internal customer teams required for the successful deployment and maintenance of LIMS System
  • Engage and work with LIMS software vendors and/or consultants to further configure the system, deploy functional enhancements, and correct configuration issues
  • Responsible for the master data management process including the updating of specifications and supporting the approval process
  • Provide incident diagnosis and support business users in the management and timely resolution of technical incidents

 

 

Education and Experience:

BS/BA in Computer Science, Information Technology or equivalent discipline

 

Knowledge, Skills, and Abilities:

  • 4 years’ experience in the pharmaceutical or biotechnology industry
  • Knowledge of GxP, FDA regulations, 21 CFR Part 11, 210, 211 and 820 compliance
  • Minimum of 3+ years' experience in primary LabWare or MODA LIMS administration or a similar system administration work
  • Minimum of 3 years of experience with Business Analysis 
  • Secondary experience with the administration of LabWare or MODA LIMS is a bonus
  • Experience with the administration of Agilent OpenLab is a bonus
  • Must possess strong knowledge of laboratory technology systems development life cycle, application development or systems integration

 

EEO Statement

Pacira is proud to be an Equal Opportunity Employer and does not discriminate against applicants because of race, color, religion, sex (including gender identity, sexual orientation, and pregnancy), national origin, age (40 or older), veteran status, disability or genetic information, or any other characteristic protected under applicable federal, state, or local law.

At Pacira we are committed to intentionally cultivating a culture of inclusion where all feel welcomed and valued for their background, perspectives, and experiences. We hold one another accountable to promote trust and transparency in support of our communities and collective purpose.