Quality Assurance (QA) Validation Specialist
Company: CAMRIS International
Location: Silver Spring
Posted on: May 3, 2021
CAMRIS International, LLC is a medical research and development
firm that realizes innovative solutions to health and development
challenges through high-quality, cost-effective program and
research management services. We combine our proven systems with
today’s most effective, evidence-based best practices to improve
the lives of people around the world. Our core practice areas
include HIV/AIDS, microbiology and infectious disease research,
vaccine research, development and production, global health
security, biodefense, and clinical research.
We are seeking a Quality Assurance Validation
Specialist I/II to support the Pilot Bio-Production
Facility (PBF) at the Walter Reed Army Institute of Research
(WRAIR) in Silver Spring, Maryland.
and responsible for the lifecycle management of instrument,
equipment and system validation at the Walter Reed Pilot
the QA Manager in developing, maintaining, and administering the
PBF Validation Policy, Validation Master Plan(s) and all SOPs
related to the site's validation.
the QA Manager in projects associated with equipment lifecycle,
validation, and calibration responsibilities.
validation protocols, and reports; reviews and approves protocols
and reports developed by validation service providers and equipment
validation activities performed by contract service
with writing, reviewing, and executing User Requirements
Specifications for instruments, equipment, and systems.
with equipment owners to define and execute the activities required
to bring equipment into GMP service (risk assessment, validation,
calibration, SOP generation, preventive maintenance
with Quality Control, Operations, Biologics Process Development,
and Facilities to investigate and resolve deviations through
determining root cause, product impact, and appropriate corrective
and preventive actions related to equipment or validated process
audits, assists in providing responses to audit observations, and
manages audit related CAPA commitments for equipment and systems,
Equipment History Files and logs.
PBF departmental metrics related to equipment and validation on a
monthly basis or when necessary.
- Leads PBF
Quality Assurance at PBF Quarterly Quality meetings and other
ad-hoc meetings when directed.
service vendors when necessary.
other duties as assigned.
Bachelor’s degree in engineering or sciences degree with additional
industry experience. Masters in Engineering or PhD in related
years of relevant cGxP experience in a biopharmaceutical or life
sciences development or manufacturing environment in calibration,
validation, operations, and engineering.
cGxP validation experience, including lab instrumentation, process
equipment, and Quality Control instrumentation.
experience in Computer Systems Validation (CSV) experience
including laboratory computer systems, laboratory information
management systems (LIMS), SCADA/monitoring systems and building
to interpret engineering drawings and design
with related fields, such as microbial physiology, general
microbiology, microbial fermentation, mammalian cell culture,
physical chemistry, and biochemistry.
using DocuSign for workflow management and implementing/using
enterprise content management platforms preferred.
at Microsoft office, especially MS Excel and Word.
in the compilation of upstream electronic and offline
and effective presentation of process data to internal and external
peers, customers, and stakeholders.
International, LLC offers competitive salaries and comprehensive
benefits. Please submit your resume online at CAMRIS.com. CAMRIS is an Equal
Opportunity/Affirmative Action Employer. All qualified applicants
will receive consideration for employment without regard to race,
color, religion, sex, national origin, age, protected veteran
status, disability status, or any other characteristic protected by
any applicable federal, state, or local law.
Keywords: CAMRIS International, Silver Spring , Quality Assurance (QA) Validation Specialist, Other , Silver Spring, Maryland
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