QA Calibration Specialist

Frederick National Laboratory for Cancer Research; Frederick (MD); On-site; USD 49,200 - 72,439; Full time

Benefits offered by this job

Health and Wellness programs

Competitive compensation

Paid Leave

Retirement benefits

Job summary

The Frederick National Laboratory for Cancer Research is hiring a Calibration Technician to perform calibration and instrument testing for the Vaccine Clinical Materials Program. This role requires a Bachelor’s degree and entails creating standard operating procedures and maintaining compliance with FDA regulations.

The technician will manage calibration databases, support the manufacture of clinical-stage vaccines, and ensure all instruments meet high standards of quality and accuracy.

Qualifications

• Possession of a Bachelor's degree from an accredited college or university.
• No experience required with a Bachelor’s degree.
• Good writing skills and ability to communicate effectively.

Responsibilities

• Perform equipment and instrument calibration and testing.
• Maintain calibration work in the RAM database.
• Create and revise departmental Standard Operating Procedures (SOPs).

Skills

Basic Microsoft Office skills

Quality systems compliant with FDA regulations for cGMP

Database maintenance and data entry

Calibrating controlled temperature units

Education

Bachelor’s degree in a related field

Tools

Blue Mountain Regulatory Asset Management

Job description

Overview

Job ID: req4612

Employee Type: nonexempt full-time

Division: Clinical Research Directorate

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

• 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

• 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 CO 2).
• 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 is 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. More details are available here.

Salary range: 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 responsibilities of the job, education, experience, knowledge, skills, and abilities, as well as internal equity and market data. The salary range posted is a full-time equivalent salary and will vary depending on scheduled hours for part-time positions.