Metrology Associate I

Overview

Cook MyoSite, Inc., part of the Cook Group, Inc. family of companies, is on a mission to make regenerative medicine a part of everyday medicine. We're investigating our core technology, autologous muscle-derived cells, for the potential treatment of several muscle-related disorders. We at Cook MyoSite have the potential to make a difference in the lives of countless people around the world, and we also have the potential to make a difference in yours. Joining our team is an opportunity to ignite your passion, grow your potential, and define your purpose. If you're curious, motivated by helping others, and driven by integrity, we invite you to apply.

The Metrology Associate I assists in supporting company operations by monitoring and controlling laboratory equipment and production related utilities, as well as assist with facility related aspects of equipment and the quality system.

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

Qualifications

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 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

Full Time On Site

Physical Requirements :

Employee that does not interact with Healthcare Professionals

Compliance with all policies of the company including without limitation the Cook Employee Manual, Cook Code of Conduct, Quality System Manual, Cook Electronic Information Policy and HIPAA regulations.

At Cook MyoSite, we don't just accept difference - we celebrate it, we support it, and we thrive on it for the benefit of our employees, our products, and our community. Cook MyoSite is proud to be an equal opportunity workplace.

This job description features the essential and critical functions of the position described and is not an exhaustive list of tasks and / or responsibilities. This may be subject to change at any time due to reasonable accommodation or other reasons.