QA Calibration Specialist III

Job

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.

Accountability, Compassion, Collaboration, Dedication, Integrity and Versatility; it's the FNL way.

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.
• Perform equipment and instrument calibration and testing to meet preapproved specifications and perform adjustments as required.
• Create and maintain all calibration work in the Regulatory Asset Management database used to track the status of instrumentation used in cGMP manufacturing.
• Review executed instrument calibration records.
• 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.
• Training Calibration Specialist I/II on Calibration principles and execution of complex equipment.

To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:

• 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, Validation or Facilities/Engineering may be substituted for the required education). Foreign degrees must be evaluated for U.S. equivalency.
• In addition to the education requirement, a minimum of five (5) years of progressively responsible Calibration experience.
• Must possess basic Microsoft Office skills.
• Must understand quality systems compliant with FDA regulations for cGMP.
• Must have a working knowledge of all aspects of calibration.
• Must have experience calibrating controlled temperature units (refrigerators, freezers, incubators) for temperature/humidity/CO₂.
• Must have experience calibrating utility systems such as Water For Injection, Steam, and Compressed gases for temperature/pressure.
• Must have experience calibrating equipment such as autoclaves, ovens, and isolators.
• An orientation to…