QA Specialist II, Calibration

Job ID: req4249

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

• 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 audits and risk assessments.
• 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.
• Review executed instrument calibration documentation.
• Compile data and prepare Instrument Calibration 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.
• Initiate and manage Out of Tolerance Quality Records in Master Control.
• Write and submit purchase requests for calibration services and equipment purchases and work with purchasing department to ensure timely approval or receipt.
• Ensure appropriate supply of materials is available for calibration activities and process purchase orders as needed.
• Work with QA Calibration management, system/equipment owners and Compliance to ensure all vendors are qualified prior to use.
• For new equipment, will work with system/equipment owners, Facilities, and Equipment Validation to author SOPs and determine what calibrations are appropriate and whether vendor assistance is required for those calibrations.
• Train staff as needed in performance of routine calibration of all controlled rate temperature units at the facility.
  
  

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 or four (4) years relevant experience in Quality Assurance Calibration in lieu of degree. Foreign degrees must be evaluated for U.S. equivalency.
• In addition to the education requirement, must have at least two (2) years of experience.
• 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.
• Experience in a cGMP environment.
• Basic knowledge of cGMP requirements as it relates to maintaining calibrated instrumentation.
• Must possess basic Microsoft Office skills.
• 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 Qualifications

• 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 with Blue Mountain Regulatory Asset Management database.
• Experience working in an environment regulated by Standard Operating Procedures (SOPs).
• Experience with electronic document management systems.
• Experience with Master Control.
• Experience working with vendors and contractors.
  
  

JOB HAZARDS

• This position is subject to working with or have 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. More details are available here

68,000.00 - 116,875.00

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