QA Calibration Specialist

QA Calibration Specialist Job ID: req4554 Employee Type: exempt full-time Division: Clinical Research 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.

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

Perform equipment and instrument calibration and testing 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. Review executed instrument calibration. 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.

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 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 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 equipment owners and staff. Experience in maintaining databases and data entry. Must be able to obtain gown certification and work aseptically in clean room conditions. This position is considered safety sensitive 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). Experience Calibrating controlled temperature units (i.e., refrigerators, freezers, incubators for temperature, humidity and CO2). Experience Calibrating facility utilities (i.e., WFI, compressed gases). Experience Calibrating autoclaves and ovens. Experience with Master Control. Experience with electronic Document Management Systems.

JOB HAZARDS

This position is subject to working with or has the potential for exposure to infectious material, requiring medical clearance and immunizations. Commitment to Non-Discrimination All qualified applicants will receive consideration for employment without regard to sex, race, ethnicity, color, 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. Pay and Benefits Pay and benefits are fundamental to any career decision. That's why we craft compensation packages that reflect the importance of the work we do for our customers. Employment benefits include competitive compensation, Health and Wellness programs, Income Protection, Paid Leave and Retirement.

49,200.00 - 72,439.00 USD

The posted pay range for this job is a general guideline and not a guarantee of compensation or salary. Additional factors considered in extending an offer include, but are not limited to, responsibilities of the job, education, experience, knowledge, skills, and abilities as well as internal equity, and alignment with market data. The salary range posted is a full-time equivalent salary and will vary depending on scheduled hours for part time positions. #J-18808-Ljbffr Initial Therapeutics, Inc.