Company:  Confidential

Job Title: GMP Equipment Calibration and Maintenance Coordinator(contract)

Job Number: 34904

Location: Cambridge, MA

Job Description

We are eeking a GMP Equipment Calibration and Maintenance Coordinator to manage and oversee the maintenance, calibration, and operational readiness of our essential manufacturing equipment

Responsibilities

  • Maintain the schedule for the calibration, maintenance and qualification of GMP equipment and instruments, ensuring that contracted service providers are proactively scheduled to perform these activities and that local equipment owners have been notified of these activities in advance.
  • Maintains up-to-date equipment identification and other metadata within the computerized calibration and maintenance management system.
  • Review and approve calibration and preventive maintenance records, storing them after approval in a manner that ensures their ready retrievability from electronic systems.
  • Promptly notify Quality Assurance of any failing activities.
  • Ensure calibration, preventive maintenance and qualification activities are captured in available logbook entries.
  • Provide regular (monthly) status reports to Quality Assurance (QA), working with the QA team to close performance gaps and implement preventive actions.
  • Ensure GMP equipment is properly labeled and identified.
  • Schedule installation and operational qualification of GMP equipment.
  • Assist equipment owners with the creation of Standard Operating Procedures for the operation, cleaning, and maintenance of GMP equipment.
  • Identifies revisions, deletions, or additions of equipment or instruments to the calibration and maintenance inventory.
  • Remove and rectify equipment that is overdue for service, out of tolerance or otherwise unfit for use.

Required Skills

Qualifications:

  • 2-4 years of relevant or transferrable experience.
  • Ability to quickly learn industry and quality concepts and standards such as ISO 17025 and GMP
  • Associate’s Degree from a two-year college or technical institution minimum.
  • Ideal candidate is highly responsible, dependable, and works exceptionally well in a team environment.

 

Apply for job

To apply for this job please visit k7y.pl.