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QA Calibration Specialist
4 months ago
QA Calibration Specialist
Job ID: req3960
Employee Type: nonexempt full-time
Division: Clinical Research Program
Facility: Frederick: G-WAY
Location: 7116 Geoffrey Way, Frederick, MD 21704 USA
The Frederick National Laboratory is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute (NCI) and 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.
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
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.
BASIC QUALIFICATIONS
To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:
No experience required with a Bachelors degree.
Must possess basic Microsoft Office skills.
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.
Ability to obtain and maintain a security clearance
PHYSICAL REQUIREMENTS
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:
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).
Commitment to Diversity
All qualified applicants will receive consideration for employment without regard to sex, race, ethnicity, age, national origin, citizenship, religion, physical or mental disability, medical condition, genetic information, pregnancy, family structure, marital status, ancestry, domestic partner status, sexual orientation, gender identity or expression, veteran or military status, or any other basis prohibited by law. Leidos will also consider for employment qualified applicants with criminal histories consistent with relevant laws.
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