What are the responsibilities and job description for the GCLP Quality Associate position at Frederick National Laboratory for Cancer Research?
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 :
PREFERRED QUALIFICATIONS
Candidates with these desired skills will be given preferential consideration :
JOB HAZARDS
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.
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
