Metrology Associate I

Cook GroupPittsburgh, PA
Onsite

About The Position

Cook MyoSite, Inc., part of the Cook Group, Inc., is dedicated to making regenerative medicine a part of everyday medicine by investigating autologous muscle-derived cells for treating muscle-related disorders. Joining their team offers an opportunity to make a difference in people's lives and advance your career. The Metrology Associate I role supports company operations by monitoring and controlling laboratory equipment and production utilities, and assists with facility-related aspects of equipment and the quality system.

Requirements

  • High school diploma or equivalent with at least 2 years previous experience with laboratory equipment in a manufacturing facility.
  • Minimum of 1-3 years' experience in metrology, calibration, or maintenance at a regulated GMP manufacturer.
  • Proficient knowledge of Microsoft Office software, and other general office equipment.
  • Basic understanding of cGMP, 21 CFR Part 11, and related regulations associated with Bio/Pharmaceutical product manufacturing.

Responsibilities

  • Perform the proper receiving, tracking and storing of purchased equipment.
  • Perform in-house calibrations and preventive maintenance activities including general-purpose test equipment, industrial equipment and laboratory equipment utilizing the site computerized maintenance management system (CMMS).
  • Responsible for notifying Metrology Manager and System Owners of any equipment issues.
  • Ensure that all measuring and test equipment used is registered, assigned and marked with a unique internal equipment number for identification.
  • Organize files and maintain all laboratory equipment records.
  • Ensure vendors maintain the facility and laboratory equipment as it relates to the specific service being provided.
  • Escort and oversee vendors throughout the facility and in the manufacturing suite.
  • Assist in maintaining all equipment procedures and specifications.
  • Provide assistance in the organization and maintaining a preventive maintenance schedule for utilities that impact the facility and assist in monitoring alert systems to ensure facilities and equipment operates within defined specifications.
  • Respond to alarms for equipment on monitoring alert system.
  • Promotes GLP/cGMP environment and follows procedural guidelines.
  • Understand and maintain up-to-date knowledge of lab equipment.
  • Support in maintaining cleanroom environment below alert limits by participating in and following established cleaning practices.
  • Provide OJT training to applicable staff for all department activities.
  • Exemplifies Cook MyoSite Core Values.
  • Maintain regular and punctual attendance.
  • Must maintain company quality and safety standards.
  • This position requires an ongoing commitment to upgrading knowledge, job skills and abilities in addition to competency related to all duties and responsibilities listed above.
  • Ability to work in collaborative and independent work situations and environments with minimal supervision.
  • Maintain composure and competence under stressful situations; demonstrate flexibility and adaptability.
  • Must work and interact effectively and professionally with and for others throughout various levels of the global organization to achieve company goals.
  • Trainability.
  • Must have effective verbal, written and interpersonal skills.
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