GCLP Quality Associate

Job ID: req4202

Employee Type: exempt full-time

Division: Vaccine, Immunity and Cancer

Facility: Frederick: ATRF

Location: 8560 Progress Dr, Frederick, MD 21701 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 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.

The Vaccine, Immunity, and Cancer Directorate (VICD) at the Frederick National Laboratory has a primary mission to provide scientific leadership and laboratory infrastructure to study immune responses to Human Papillomavirus (HPV) vaccines and other cancer preventive strategies in the context of clinical and pre-clinical studies. More recently, VICD is also leading initiatives on SARS-CoV-2 infection and vaccines.

Our core values of accountability, compassion, collaboration, dedication, integrity, and versatility serve as a guidepost for how we do our work every day in serving the public’s interest.

Key Roles/Responsibilities

• Conduct routine and non-routine analysis of samples, including quality control samples, standards and reagents according to standard operating procedures (SOPs).
• Conduct assay validation, including robotics testing.
• Participate in the development of QC samples and procedures.
• Evaluate critical reagents and bridge experiments to qualify critical reagents and release lots for use in laboratory testing.
• Participate in critical reagent release generating applicable certificate of analysis in the event a new lot is released.
• Review batch records, document review, quality control testing review, and test results for completeness, accuracy, and conformance to specifications; investigates deviations and plan corrective actions with laboratory management and assist with corrective actions, in conjunction with laboratory personnel.
• Perform required data analysis, review data, interpret data findings, investigate issues and report abnormalities, troubleshoots analytical methods, on daily basis, ensuring findings and investigations are timely.
• Responsible for performing routine maintenance and troubleshooting on lab equipment and procedures.
• Assist monitoring equipment within the laboratory.
• Participate in out-of-specification investigations and recommend corrective actions.
• Draft and revise SOPs, data sheets and reports, as assigned.
• Provide accessibility and quality support to the laboratory staff on an on-going basis.
• Assist with scanning, and archiving of laboratory records as needed.
• Provide hands-on support to laboratory personnel including Laboratory Manager and Quality Manager to perform evaluation of laboratory internal controls, deficiencies, corrective action plans, and follow up of quality events (deviations, corrective and preventive actions, etc.) across the laboratory operations.
• Prepare and submit data summaries for review.
• Maintain, review, promote a high standard of documentation practices to ensure appropriate documentation of quality control test results.
• Follow good documentation practices to ensure appropriate documentation of test results.
• Maintain the safety and orderliness of the lab, in coordination with the Laboratory Manager, Quality Manager, and laboratory staff, implement appropriate actions as needed.
• Ensure compliance with SOPs, and GCLP regulations.
• Provide daily quality support to staff as needed, onsite and in laboratory settings.
  
  
  

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/university according to the Council for Higher Education Accreditation (CHEA) in a related field (additional qualifying experience may be substituted for the required education). Foreign degrees must be evaluated for U.S. equivalency.
• In addition to the education requirement, a minimum of two (2) years of related experience.
• Ability to follow SOPs and comply with GCLP.
• Experience working with immunology and molecular biological techniques including ELISA, Luminex and other multiple assays, viral neutralization assays, RT-PCR, plasmid and protein production.
• Ability to work with electronic database systems such as LIMS.
• Knowledge of Bioanalytical laboratory equipment.
• Detail oriented with strong organizational and verbal communication skills.
• Ability to work well in a team environment.
• Must be able to commute to work location and work onsite. No telework or hybrid option is allowed for this position.
• Ability to obtain and maintain a security clearance.
  
  
  

Preferred Qualifications

Candidates with these desired skills will be given preferential consideration:

• Experience using reference materials.
• Experience with immune assay (ELISA, multiplex assays) development and validation.
• Understanding of regulatory and GCLP/CLIA requirements.
• Experience with robotics and assay automation.
  
  
  

JOB HAZARDS

• This position is subject to working with or have potential for exposure to infectious material, requiring medical clearance and immunizations.
  
  
  

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.

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.

56,200.00 - 96,625.00

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.

#readytowork

The salary range posted is a full-time equivalent salary and will vary depending on scheduled hours for part time positions