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