Senior Quality Assurance Specialist
Company: Icosavax Inc.
Location: Seattle
Posted on: May 16, 2022
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Job Description:
SUMMARY: Icosavax, Inc. (NASDAQ: ICVX) is a publicly traded
biopharmaceutical company leveraging its innovative VLP platform
technology to develop vaccines against infectious diseases, with an
initial focus on life-threatening respiratory diseases. Icosavaxs
VLP platform technology is designed to enable multivalent,
particle-based display of complex viral antigens, which it believes
will induce broad, robust, and durable protection against the
specific viruses targeted. Icosavaxs pipeline includes vaccine
candidates targeting respiratory syncytial virus (RSV), human
metapneumovirus (hMPV), and severe acute respiratory syndrome
coronavirus 2 (SARS-CoV-2). Based in Seattle, Icosavax was formed
in 2017 to advance the breakthrough VLP technology from the
Institute for Protein Design at the University of Washington with
the goal to discover, develop, and commercialize vaccines against
infectious diseases. OBJECTIVE: Icosavax seeks to hire a Senior
Quality Assurance Specialist with biotech vaccine experience for
our Quality Team. This position will play a key role in supporting
GMP/GCP quality operations including, CMC Development,
Manufacturing, Clinical and Quality Systems. The successful
candidate will interface with key Icosavax functional and
cross-functional teams, as well as our CDMO/CRO partners for
vaccine development, manufacturing, testing, supply chain and
clinical activities. The successful candidate will be highly
self-motivated, productive, a quick learner, and creative. They
will be comfortable partnering with Icosavaxs CMC Development and
Clinical Teams to manage GMP/GCP activities and issue escalation.
They will have excellent problem-solving skills as well as strong
written and verbal communication skills. This position requires an
independent strategic thinker motivated by performance excellence
and team success, someone who can roll up their sleeves and assist
where needed, working within a lean operations team and partnering
with employees at all levels of the organization. The successful
candidate will be a positive and enthusiastic team player, able to
work with moderate guidance and take pride in the quality and
timely delivery of their work. RESPONSIBILITIES Lead and oversee
audits at contract manufacturing, research, testing, packaging, and
warehouse/distribution operations. Responsible for annual audit
schedules. Review and approve documentation of GMP/GCP activities
at contract facilities. Responsibilities for day-to-day
interactions with contract facilities. Conduct investigation into
GMP and GCP related issues or problems associated with audit, batch
records, complaints, and clinical studies. Approve deviations and
investigations into out-of-specification results. Approve internal
CAPA. Manage internal CAPA system. Review and approve manufacturing
batch records and Quality Control test records. Review and approve
documentation for tech transfer and qualification/validation of
analytical method and manufacturing processes. Approve stability
protocols and final reports. Ensure expiration dates are assigned
per site procedures. Conduct internal audits. Maintain QA records
according to applicable regulatory requirements and Icosavax
policy. Draft and review internal GMP/GCP documents such as
standard operating procedures, certificates of analysis and
specifications. Provide QA tracking and trending information to
Icosavax management. Provide GMP/GCP training to Icosavax staff and
contractors. Other duties as assigned. Qualifications: Bachelors
Degree or higher in scientific discipline. Minimum of 6 years of
experience in quality or regulatory compliance within the
pharmaceutical, biologics or other related industries. Experience
leading internal and external audits. GMP and/or GCP experience
required. Excellent communication skills both oral and written.
Experience working as part of multi-functional team. Effetely
represent the Quality organization both internally and externally.
Experience with electronic quality management systems preferred.
Proficiency with standard project management, virtual
communication, and cloudbased documentation tools. PHYSICAL
DEMANDS: Manual dexterity required to operate office equipment
(i.e., computers, phones, etc.). May require 25% offsite travel.
Some international travel may be required.by Jobble
Keywords: Icosavax Inc., Seattle , Senior Quality Assurance Specialist, Professions , Seattle, Washington
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