Leidos QA Calibration Specialist (NCI) in FREDERICK, Maryland

Description:

PROGRAM DESCRIPTION

The Vaccine Clinical Materials Program (VCMP) is responsible for the overall direction of the operations/manufacturing of the vaccine and biotherapeutic development facility for the development of experimental therapeutics for pre-clinical and Phase I and II clinical trials targeting a range of infectious diseases.

KEY ROLES/RESPONSIBILITIES

Reporting to the QA Validation Manager, this position will:

  • Perform equipment and instrument calibration and testing using NIST traceable standards 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

  • Cross-train with validation engineers to perform equipment validations, operation and performance qualification protocols

  • Review executed instrument calibration and validation documentation

  • Compile data and prepare final reports

  • 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

Qualifications:

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. (Additional qualifying experience 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 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 staff

  • Experience in maintaining databases and data entry

  • Working knowledge of Microsoft Office

  • Must be able to obtain and maintain a security clearance

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)

Expected Competencies:

  • Entry professional role, contributing in a support capacity by receiving instruction, guidance, and direction from others

  • Accountable for meeting own targets which impact the immediate work area

  • Impact is limited to short-term team performance

  • Responsible for planning own work, assessing own progress, and adjusting efforts to meet goals

  • Applies knowledge of standardized rules, procedures, and operations within own area

  • Determines a course of action based on guidelines and competence developed by performing structured work assignments

  • Uses existing procedures to solve routine or standard problems, and occasionally requires basic problem solving techniques to define problems

  • Audience is generally knowledgeable about the subject matter but may be required to interpret or clarify technical information to aid understanding

Leidos Overview:

Leidos is a global science and technology solutions leader working to solve the world’s toughest challenges in the defense, intelligence, homeland security, civil, and health markets. The company’s 33,000 employees support vital missions for government and commercial customers. Headquartered in Reston, Virginia, Leidos reported pro forma annual revenues of approximately $10 billion for the fiscal year ended January 1, 2016 after giving effect to the recently completed combination of Leidos with Lockheed Martin's Information Systems & Global Solutions business (IS&GS). For more information, visit www.Leidos.com. The company’s diverse employees support vital missions for government and commercial customers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status. Leidos will consider qualified applicants with criminal histories for employment in accordance with relevant Laws. Leidos is an equal opportunity employer/disability/vet.