The primary responsibility for the Metrology Specialist I is the coordination of group activities such as equipment maintenance/repair and equipment validation. These activities includes developing equipment validation plans and writing/reviewing documents in support of the change control process. Secondary responsibilities include managing the receipt/shipment of equipment, managing outsource calibration by vendors, preparing/reviewing deviation documentation, providing support during audits, and other tasks as needed to support the primary responsibilities. 

 

Principal Duties and Responsibilities

• Operates within the Quality Management System applicable to the manufacture of phase appropriate material in the CMF.
• Maintains compliance with applicable regulatory requirements for cellular and gene therapy products.
• Demonstrates attention to detail in all job functions.
• Performs in accordance with established policies, procedures, and techniques and requires training common experience or working knowledge related to the tasks performed.
• Works to specific measurable objectives requiring operational planning skill with little direct supervision.
• Cultivates a diverse and collaborative team environment. Utilizes clear and concise communication to deliver high productivity and contribution to the success of department goals.
• Oversees the equipment calibration program.
• Authors and reviews department SOP’s, risk assessments, and equipment validation protocols.
• Communicates with equipment users for procedure updates.
• Mentors equipment users on new equipment.
• Identifies root causes for equipment failures.
• Performs calibrations.
• Exercises crucial people skills.
• Exercises discretion, judgment and personal responsibility.
• Demonstrates high level of integrity.
• Maintains positive attitude.
• Any and all other duties as assigned.

 

Knowledge, skills and abilities required

• Requires a relevant four-year degree   
• No minimum years of experience.
• Experience in highly regulated field preferred.
• Must be computer literate with experience in Microsoft Office products.

 

Minimum Physical Requirements

• There are very minimal physical requirements.  One needs to be able to lift 20-30 poun 
• May require ability to aseptically gown or wear other PPE on regular basis
• Must be able to stand for extended periods

EOE M/F/Disability/Vet