QA Specialist IV
Location: Frederick
Posted on: June 23, 2025
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Job Description:
QA Specialist IV Job ID: req4316 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 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, Immunity and Cancer Directorate (VICD) at the
Frederick National Laboratory investigates immune responses to
vaccines in preclinical and clinical studies. The Frederick
National Laboratory (FNL) and other stakeholders to develop assays
with the highest reproducibility, sensitivity, and specificity for
evaluation of immune responses against this new virus. To address
gaps and unmet needs in serology assay development and
standardization and to gain a solid fundamental knowledge of the
immune response to underlying mechanisms of protection against
infection, leveraging the vast expertise and excellence in HPV
serology at the FNL. KEY ROLES/RESPONSIBILITIES The Vaccine,
Immunity and Cancer Directorate is seeking an energetic and
seasoned Quality Assurance professional with experiences preferably
in Serology laboratory with strong knowledge in GCLP to lead and
support laboratory quality activities. This is a fully onsite
position with no telework option. The QA professional will: Lead
and perform continuous evaluation of internal controls,
communications, risk assessments and maintenance of documentation
as related to compliance with internal and external safety,
quality, and regulatory standards Evaluation and monitoring of
conformance to established quality assurance processes and
standards for testing and laboratory practices Identify risk and
evaluate deficiencies 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 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 Work
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 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 and 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 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). (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 eight (8) years of leading quality
assurance in GCLP or GLP environment. Highly experienced in GCLP or
GLP, CLIA. Ability to obtain and maintain a security clearance.
PREFERRED QUALIFICATIONS Candidates with these desired skills will
be given preferential consideration: 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. Excellent communication, organization,
and writing skills. 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 90,500.00 - 155,625.00 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. The salary range posted is a full-time equivalent
salary and will vary depending on scheduled hours for part time
positions
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