Our client, a world leader in biotechnology
and life sciences, is looking for a
“QA
Consultant” based out of San Diego, CA.
Job Duration: Long Term Contract (Possibility Of
Extension)
Company Benefits:
Medical, Dental, Vision, Paid Sick leave,
401K
We are seeking an experienced
QA Consultant (GxP)
to
support and enhance Quality Systems at a clinical-stage biotech facility
focused on
cell and gene therapies
.
The role will oversee
Quality
Management Systems (QMS), Document Control, EDMS, and GxP compliance
,
while ensuring regulatory alignment and operational efficiency.
Key Responsibilities:
·
Support
QMS integration and legacy system management
during system
migration.
·
Manage
GxP quality processes
including Change Control, Deviations, CAPA,
Training, and Document Control.
·
Provide oversight for
SOP updates, quality documentation, and
document lifecycle management
.
·
Monitor
quality metrics and dashboards
to maintain compliance.
·
Support
EDMS/LMS systems
such as
Qualio
and ComplianceWire
.
·
Assist with
internal/external audits and corrective action plans
.
·
Collaborate cross-functionally with
QA, QC, Manufacturing, Validation, Supply
Chain, and Clinical teams
.
Qualifications:
·
Bachelor’s degree in Life Sciences
or related field.
·
8+ years of QA experience in GxP
environments (biotech, pharma, or cell/gene therapy).
·
Strong knowledge of QMS, CAPA,
Deviations, Change Control, and Document Control.
·
Experience with EDMS/LMS systems
(Qualio, ComplianceWire preferred).
·
Ability to write/revise SOPs and
quality documentation.
If interested, please send us your updated resume at

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