QA Calibration Specialist III

PROGRAM DESCRIPTION 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. KEY ROLES/RESPONSIBILITIES 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. BASIC QUALIFICATIONS 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/CO 2 . 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 teamwork and a commitment to quality and customer satisfaction are essential. Must have the 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. Must have good writing skills Must be able to obtain gown certification and work aseptically in clean room conditions. This position is considered a safety-sensitive position and will be subject to random drug testing per the Leidos Biomedical Research Drug Free Workplace Program. Ability to obtain and maintain a security clearance. PHYSICAL REQUIREMENTS Physical requirements include the ability to maintain balance at all times, walk, kneel, hear (corrective appliance allowed), use of both hands, arms and legs (prosthetic allowed), use of all fingers, carry up to 50lb, reach above shoulders, climb ladders, push/pull, repeated bending and stand for extended periods. Ability to respond to verbal instruction and cues in a sterile environment where staff are wearing face masks. Ability to wear Personal Protective Equipment (PPE) Ability to Enter a Laboratory or Encounter a Hazardous Area Ability to Operate and/or service equipment that contacts or transports compressed or liquid gas. Ability to withstand exposure to temperatures below 32 degrees indoors for small amounts of time. Visual acuity to include depth perception, color distinction, and vision correctable to 20/40. Pacemaker prohibited. 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). Ability to prepare timelines and project schedules using computer applications. Experience with Master Control. Experience with electronic Document Management Systems. JOB HAZARD This position is subject to working with or has the potential for exposure to infectious material, requiring medical clearance and immunizations.