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Frederick National Laboratory for Cancer Research
Frederick, MD | Temporary
$112k-135k (estimate)
1 Week Ago
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Quality Assurance Specialist IV
$112k-135k (estimate)
Temporary
1 Week Ago
Frederick National Laboratory for Cancer Research is Hiring a Quality Assurance Specialist IV Near Frederick, MD
Job ID: req3953
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.
This position description does not represent a specific job but represents a sourcing announcement for current and future open positions. Our positions span a wide range of skills, so candidates who express an interest may be considered for upcoming positions at Frederick National Laboratory for Cancer Research.Program DescriptionThe 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, other cancer preventive strategies and SARS-CoV-2 in the context of clinical and pre-clinical studies.
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/ResponsibilitiesThe Vaccine, Immunity and Cancer Directorate is seeking an energetic, collaborative and seasoned Quality Assurance professional with experiences preferably in Serology laboratory setting with strong knowledge in GCLP to lead and support laboratory quality activities. This is a fully onsite position with no telework option. This is a temporary assignment with a potential for permanent appointment. The QA professional will:
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.
#readytowork
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.
This position description does not represent a specific job but represents a sourcing announcement for current and future open positions. Our positions span a wide range of skills, so candidates who express an interest may be considered for upcoming positions at Frederick National Laboratory for Cancer Research.Program DescriptionThe 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, other cancer preventive strategies and SARS-CoV-2 in the context of clinical and pre-clinical studies.
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/ResponsibilitiesThe Vaccine, Immunity and Cancer Directorate is seeking an energetic, collaborative and seasoned Quality Assurance professional with experiences preferably in Serology laboratory setting with strong knowledge in GCLP to lead and support laboratory quality activities. This is a fully onsite position with no telework option. This is a temporary assignment with a potential for permanent appointment. The QA professional will:
- Lead continuous performance evaluation of internal controls, communications, risk assessments and maintenance of documentation, including SOPs, as related to compliance with internal and external safety, quality, and regulatory standards for GCLP
- Evaluation and monitoring of conformance to established quality assurance processes and standards for testing and laboratory practices
- Identify risk and evaluates deficiencies and deviations in a routine basis while working with internal departments/business units to appropriately remedy them
- Develop appropriate risk management strategies
- Assist staff with the creation, implementation, and follow up of Corrective and Preventive Actions
- Implement and develop appropriate Corrective and Preventive Actions Program in collaboration with VICD management/leadership. Recommend alternative courses of action and possible solutions for improvement of workflow, and paperwork management
- Work with laboratory director and manager to plan, qualify, verify, and validate tests/assays and equipment
- Working closely with the laboratory to write SOPs and Quality Assurance plans appropriate for each group
- Participate in the review and revision of standard operating procedures to adhere to regulatory regulations
- Working closely with appropriate staff, prepare standard operating procedures for quality control activities
- Review documents for content, accuracy and compliance
- Develop and monitor quality assurance standards
- Prepare guidance documents
- Review records, test results and data for completeness, accuracy, and compliance with specifications and requirements
- Facilitate internal training and quality assurance requirements, processes, and procedures, and maintain training records for staff
- Maintain document control system and ensure version control for all standard operating procedures
- Lead and perform internal audits, identify deficiencies, recommend improvements and make risk assessments
- Implement training programs for laboratory personnel on quality assurance requirements, processes, and procedures
- Ensure compliance with SOPs, GCLP/CLIA regulations, and FDA as applicable
- Possession of Bachelor’s degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) or four (4) years relevant experience in lieu of degree. Foreign degrees must be evaluated for U.S. equivalency
- In addition to the education requirement, a minimum of five (5) years of experience working in GCLP or GLP environment
- Trained in GCLP or GLP
- Excellent communication, organization, and writing skills
- Ability to obtain and maintain a security clearance
- Experience in quality control and quality assurance related to immunology, virology and/or molecular biology procedures for reagent production and assay development and performance
- Strong understanding of regulatory and GCLP/CLIA requirements
- Experience working with standards and reference materials, immune assay (ELISA, multiplex assays) development and validation
- This position is subject to working with or have potential for exposure to infectious material, requiring medical clearance and immunizations
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.
#readytowork
Job Summary
JOB TYPE
Temporary
SALARY
$112k-135k (estimate)
POST DATE
06/09/2024
EXPIRATION DATE
06/30/2024
WEBSITE
frederick.cancer.gov
HEADQUARTERS
Frederick, MD
SIZE
200 - 500
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The job skills required for Quality Assurance Specialist IV include Quality Assurance, SOP, Leadership, Quality Control, Internal Audit, Standard Operating Procedures, etc. Having related job skills and expertise will give you an advantage when applying to be a Quality Assurance Specialist IV. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Quality Assurance Specialist IV. Select any job title you are interested in and start to search job requirements.
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The following is the career advancement route for Quality Assurance Specialist IV positions, which can be used as a reference in future career path planning. As a Quality Assurance Specialist IV, it can be promoted into senior positions as a Quality Assurance Specialist V that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Quality Assurance Specialist IV. You can explore the career advancement for a Quality Assurance Specialist IV below and select your interested title to get hiring information.
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