QA Calibration Specialist III

About the role

The Vaccine Clinical Materials Program (VCMP) at the Frederick National Laboratory supports the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center (VRC). The program operates a pilot plant facility and is involved in cGMP manufacture, testing, release, and supply of clinical products.

Responsibilities

• Affords support to the organization with initial compliance and ongoing preparation, testing, and monitoring of quality assurance processes and standards for manufacturing and production.
• Performs evaluation of internal controls, communications, risk assessments, and maintenance of documentation related to compliance with internal and external safety, quality, and regulatory standards.
• Identifies risks and evaluates deficiencies, collaborating with internal departments/business units to remediate them.
• Facilitates internal training on quality assurance requirements, processes, and procedures.
• May participate in cross-functional teams conducting risk assessments.
• Performs equipment and instrument calibration and testing to meet pre-approved specifications and performs necessary adjustments.
• Creates and maintains calibration work in the Regulatory Asset Management database used to track instrumentation used in cGMP manufacturing.
• Reviews executed instrument calibration records.
• Compiles data and prepares Master Calibration Records and Instrument Calibration Records.
• Creates and revises departmental Standard Operating Procedures (SOPs).
• Generates work orders.
• Prints calibration reports for daily and monthly activities.
• Maintains daily updates of completed work in the RAM database.
• Schedules calibration vendors for on-site activities.
• Manages off-site calibrations, including obtaining quotes and appropriate shipping information.
• Trains Calibration Specialists I/II on calibration principles and execution of complex equipment.

Requirements

• Possession of a Bachelor’s degree from an accredited college or university in a related field, or a minimum of five (5) years of progressively responsible Calibration experience.
• Basic Microsoft Office skills.
• Understanding of quality systems compliant with FDA regulations for cGMP.
• Experience calibrating controlled temperature units (refrigerators, freezers, incubators) for temperature/humidity/CO2.
• Experience calibrating utility systems such as Water For Injection, Steam, and Compressed gases for temperature/pressure.
• Experience calibrating equipment such as autoclaves, ovens, and isolators.
• An orientation to teamwork and a commitment to quality and customer satisfaction.
• Ability to clearly summarize and communicate calibration issues to equipment owners and staff.
• Experience in maintaining databases and data entry.
• Experience in writing/investigating Out of Tolerance conditions for equipment.
• Good writing skills.
• Ability to obtain gown certification and work aseptically in clean room conditions.

Qualifications

• Minimum of five (5) years of progressively responsible Calibration experience.
• 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).
• Ability to prepare timelines and project schedules using computer applications.
• Experience with Master Control.
• Experience with electronic Document Management Systems.

Benefits

Includes competitive compensation, Health and Wellness programs, Income Protection, Paid Leave, and Retirement. Salary range is $76,800.00 - $110,103.00 USD, subject to internal equity and market data.