Operations Specialists

Highly Competitive
  1. Permanent
  2. Good Manufacturing Practice (GMP)
  3. United States
Foster City, California
Posting date: 25 Apr 2019

ProClinical is advertising a vacancy for an Operations Specialist position with a leading pharmaceutical research company. The organization prides itself on its solid commercial portfolio of life-saving drugs within a number of therapy areas, along with a growing pipeline of investigational drugs and an unmatched patient access program. Based in the company's California office, this is an exciting opportunity to work with an internationally renowned company and support their innovative impact on the healthcare field.

Job Responsibilities:

  • Manage and process to ensure new or relocated assets are entered accurately into the Computerized Maintenance Management System (CMMS) with all asset information, preventive maintenance and calibration schedule, and appropriate job plans and data sheets
  • Be responsible for all GMP and non-GMP assets job plan creation and work order issuance during the project phase
  • Prepare all relevant documentation and work records for asset induction
  • Identify problems, generates alternatives and recommendations within defined processes
  • Meet with key stakeholders to determine user and project requirements
  • Research and troubleshoot issues within business systems and processes, escalate as necessary
  • Identify and execute actions from troubleshooting activities
  • Work with process owners to collect, organize and verify data for process improvement
  • Track project schedule and report progress regularly to management
  • Completion of all GxP and CMMS training requirements
  • Support activities including project meetings, process mapping sessions and collaboration with key functions
  • Induction of all new and relocated assets and creation of preventive maintenance and calibration schedule into the Computerized Maintenance Management System (CMMS)
  • Completion of the approval of all Job Plans by Asset Owners, Metrology and QA
  • Issuance of all work orders based on established Preventive Maintenance and Calibration schedules
  • Prepared relevant documentation and work records
  • Periodic reports on project status as it relates to the asset induction process

Skills and Requirements:

  • Bachelor's Degree is preferred.
  • Demonstrable multitasking, project management, and execution skills.
  • Good interpersonal skills, including communication, presentation, persuasion, and influence.
  • Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
  • Proficiency with computer skills, such as MS Office.

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Allison Stevens at a.stevens@proclinical.com or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.