QA Associate I
Company: Repligen Corporation
Posted on: June 1, 2021
Assurance Associate I will report directly to the QA Lead, Manager
is responsible to actively participate in the Repligen ISO 9001
Quality Management System. This role
for the Quality review of manufacturing production records,
including verification of raw materials used, verification of
calculations and critical process steps, and evaluation of Quality
familiar with Quality Control principles and concepts such as
(i.e.: Bioburden/ Endotoxin Testing, RODI testing, pH, Conductivity
familiar with Good Documentation Practices (GDP) and able to
perform root cause analysis, assist with deviations and
identification of corrective actions/ Process
record review; to include review of production records, quality
control records such as (i.e.:
weekly Environmental Monitoring records), and weekly/monthly
of process deviations.
of Out-of-Specifications (OOS) results.
the maintenance of the Repligen Quality Management Systems, as
Bind and file
completed batch records and other administrative
degree in Biological Science or other science related
· Minimum 0-2
years’ experience in Quality Assurance in an ISO 9001 certified
Quality Management System or equivalent.
· Ability to
communicate with multiple departments and associates.
· Shares timely
information with peers on daily progress.
· Ability to
contribute to project teams.
· Focus and
attention to detail is critical.
of Good Documentation Practices preferred.
Keywords: Repligen Corporation, Waltham , QA Associate I, Other , Waltham, Massachusetts
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