QA Calibration Specialist

Key Roles/Responsibilities

• Perform equipment and instrument calibration and testing to meet preapproved specifications and perform adjustments as required.
• Create and maintain all calibration work in the RAM database used to track the status of instrumentation used in cGMP manufacturing.
• Review executed instrument calibration.
• Compile data and prepare Master Calibration Records and Instrument Calibration Records.
• Create and revise departmental Standard Operating Procedures (SOPs).
• Generate work orders.
• Print out calibration reports for daily and monthly activities.
• Perform daily updates of completed work in the RAM database.
• Schedule calibration vendors for on-site activities.
• Manage off-site calibrations including working with vendors to obtain quotes and appropriate shipping information.

Basic Qualifications

• Possession of a Bachelor’s degree from an accredited college or university according to the Council for Higher Education Accreditation (CHEA) in a related field (Qualifying experience (4 years) in Calibration may be substituted for the required education).
• Foreign degrees must be evaluated for U.S. equivalency.
• No experience required with a Bachelor’s degree.
• Must possess basic Microsoft Office skills.
• Must understand quality systems compliant with FDA regulations for cGMP.
• Must have good writing skills.
• Must have the ability to clearly summarize and communicate calibration issues to equipment owners and staff.
• Experience in maintaining databases and data entry.
• Must be able to obtain gown certification and work aseptically in clean room conditions.

Preferred Qualifications

• Candidates with these desired skills will be given preferential consideration:
• Experience in a cGMP environment.
• Basic knowledge of cGMP requirements as it relates to maintaining calibrated instrumentation.
• Experience with Blue Mountain Regulatory Asset Management database.
• Experience working in an environment regulated by Standard Operating Procedures (SOPs).
• Experience Calibrating controlled temperature units (i.e, refrigerators, freezers, incubators for temperature, humidity and CO 2 ).
• Experience Calibrating facility utilities (i.e. WFI, compressed gases).
• Experience Calibrating autoclaves and ovens.
• Experience with Master Control.
• Experience with electronic Document Management Systems.