QA Calibration Specialist III

Job : req
4626

Employee Type: exempt full-time

Division: Vaccine Clinical Materials Program

Facility: Frederick: G-WAY

Location: 7116 Geoffrey Way, Frederick, MD 21704 USA

The Frederick National Laboratory is operated by Leidos Biomedical Research, Inc. The lab addresses some of the most urgent and intractable problems in the biomedical sciences in cancer and AIDS, drug development and first-in-human clinical trials, applications of nanotechnology in medicine, and rapid response to emerging threats of infectious diseases.

The Vaccine Clinical Materials Program (VCMP), part of Leidos Biomedical Research at the Frederick National Lab, supports the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center (VRC). Its mission is to advance preclinical and clinical research, product development, and manufacture of novel clinical-stage vaccines and biologics to address current and/or emerging infectious diseases of global significance (e.g., HIV-AIDS, Influenza, Ebola, Malaria, Novel Coronavirus, Tuberculosis).

The VCMP is responsible for the operation of a Frederick, MD‑based pilot plant facility and is actively engaged in cGMP manufacture, testing, release, and supply of Phase I/II clinical products for investigational use in the US and globally.

• Assists and supports the organization with initial compliance and ongoing preparation, testing and monitoring of conformance to established quality assurance processes and standards for manufacturing and production.
• Performs evaluation of internal controls, communications, risk assessments and maintenance of documentation as related to compliance with internal and external safety, quality, and regulatory standards.
• Identifies risk and evaluates deficiencies while working with internal departments/business units to appropriately remedy them.
• Facilitates internal training on quality assurance requirements, processes, and procedures.
• May perform or be part of cross‑functional teams performing risk assessments.
• Performs equipment and instrument calibration and testing to meet preapproved specifications and performs adjustments as required.
• Creates and maintains all calibration work in the Regulatory Asset Management database used to track the status of 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 out calibration reports for daily and monthly activities.
• Performs daily updates of completed work in the RAM database.
• Schedules calibration vendors for on‑site activities.
• Manages off‑site calibrations including working with vendors to obtain quotes and appropriate shipping information.
• Trains Calibration Specialist I/II on calibration principles and execution of complex equipment.

• 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 of 4 years in Calibration, Validation or Facilities/Engineering may be substituted for the required education). Foreign degrees must be evaluated for U.S. equivalency.
• Minimum of five (5) years of progressively responsible calibration experience.
• Basic Microsoft Office skills.
• Understanding of quality systems compliant with FDA regulations for cGMP.
• Working knowledge of all aspects of calibration.
• 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.
• Orientation to teamwork and 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…