*Temporary* Biodefense Regulated Quality Review Specialist
Company: Alakaina Family of Companies
Posted on: June 6, 2021
Laulima Government Solutions, LLC is looking for a qualified
Biodefense Regulated Quality Review Specialist to support our
contract with USAMRIID in Frederick, MD.
The candidate shall provide Quality Review (QR) Specialist
support to the USAMRIID's Medical Countermeasure (MCM) Advanced
Test & Evaluation (T&E) capability, to include 100% data audits
and 100% verification of final reports for both well documented and
GLP compliant studies.
Work with Chief, QARCO, Study Directors, principal
investigators, and other key staff to perform Quality Reviews of
documents and records associated with nonclinical studies, to
include those conducted under FDA Good Laboratory Practice (GLP)
Perform quality review of laboratory study files and records to
assure that calculations, content, reference, etc. are technically
correct and complete for submission for QA audit.
Generate, route and file review QR reports for each quality
Perform quality review of GLP study final reports and other high
visibility final reports to assure that calculations, content,
reference, etc. are technically correct and complete for submission
for QA audit.
Coordinate and manage corrective action/ preventive action
(CAPA) activities related to QARCO supported studies and processes
Represent QARCO in study and project team meetings, coordinating
activities with Study Directors, Principal Investigators and study
personnel. The candidate shall coordinate with QAU staff on
scheduling and quality standards for submissions for QA audit as
well as coordinating the scheduling and tracking for all quality
Ensure compliance with FDA regulations, e.g., 21CFR314, where
the goal is inclusion in FDA animal rule submission in review of
records and documents.
Write and revise department documents, such as SOPs and work
instructions; providing peer review of documents. Devise
improvements to established procedures to improve workflow and
efficiency and/or increase USAMRIID's adherence to FDA GLP
requirements, FDA regulatory expectations and Industry
Attend 1-2 conferences annually in order to obtain continuing
education and to ensure cutting edge knowledge and techniques are
Provide training to USAMRIID personnel and candidates on
regulatory topics, including training co-workers in QARCO tasks and
matters of regulatory interest at USAMRIID.
Manage, file and archive Quality Review records, to include
reports, review documentation, schedules, log records and the like
as directed IAW USAMRIID SOPs and published instructions.
Maintain, update and manage supporting systems, processes and
documents that underpin and facilitate the Quality Review Mission,
to include maintaining and updating metrics information in an
electronic database or other format, to include project
information, times, dates and the like as directed.
- Interface directly with scientific community to communicate and
coordinate data package receipt, quality review reports, findings
and corrective actions.
Required Skills and Experience:
- Quality Control/Quality Review in a GLP environment
- FDA Animal Rule experience
- Ability to read, update, and create SOPs
- Experience with incident investigation
- High functioning in a QA audit as contributor and in
Desired Skills and Experience
- Previous DoD experience
- Prior experience with assays (i.e.- ELISA and High-Performance
Liquid Chromatography (HPLC)
Laulima Government Solutions, LLC is a fast-growing government
service provider. Employees enjoy competitive salaries; a 401K plan
with company match; medical, dental, disability, and life insurance
coverage; tuition reimbursement; paid time off; and 10 paid
holidays. Laulima Government Solutions, LLC is proud to be an equal
We are an Equal Opportunity/Affirmative Action Employer of
individuals with disabilities and veterans. We are proud to state
that we do not discriminate in employment decisions on the basis of
race, color, religion, sex, pregnancy, sexual orientation, gender
identity, national origin, age, protected veteran status, or
disability status. If you are a person with a disability and you
need an accommodation during the application process, please click
here to request accommodation. We E-Verify all employees.
ina Foundation Family of Companies (FOCs) is
comprised of industry-recognized government service firms
designated as Native Hawaiian Organization (NHO)-owned and 8(a)
certified businesses. The Family of Companies (FOCs) includes
Keaki Technologies, Laulima Government Solutions, Kpono
Government Services, and Kapili Services, Po
Kkaha Solutions, LLC, and Pololei Solutions, LLC. Alakaina
Foundation activities under the 501(c)3 principally benefit the
youth of Hawaii through charitable efforts which includes providing
innovative educational programs that combine leadership, science &
technology, and environmental stewardship.
For additional information, please visit
Keywords: Alakaina Family of Companies, Frederick , *Temporary* Biodefense Regulated Quality Review Specialist, Other , Frederick, Maryland
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