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Submitted URL: https://jsv3.recruitics.com/redirect?rx_cid=3374&rx_jobId=JP-004000367&rx_url=https://ars2.equest.com/?icid=linkedin_limited...
Effective URL: https://careers.actalentservices.com/us/en/job/JP-004000367/Quality-Assurance-Specialist?utm_source=Recruitics&utm_medium=equest&s_id...
Submission: On September 06 via manual from US — Scanned from DE
Effective URL: https://careers.actalentservices.com/us/en/job/JP-004000367/Quality-Assurance-Specialist?utm_source=Recruitics&utm_medium=equest&s_id...
Submission: On September 06 via manual from US — Scanned from DE
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QUALITY ASSURANCE SPECIALIST
location Foster City, California, USA category Laboratory Sciences Contract Job
ID: JP-004000367 Posted: Aug 28th 2023 47.41 USD - 58 USD/hour
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JOB DESCRIPTION
The Quality Assurance Specialist is focused on deviations and CAPAs associated
with the batch record review of biologics pharmaceutical products.
Description:
* Performs a wide variety of activities to ensure compliance with applicable
regulatory requirements.
* Participates in developing Standard Operating Procedures to ensure quality
objectives are met.
* Facilitate, review, and approve major and minor investigations related to GxP
operations.
* Maintains programs and processes to ensure high quality products and
compliance with current Good Manufacturing Practices (GMPs).
* Reviews routine manufacturing, environmental monitoring and quality control
data for in-process and finished products.
* Develops solutions to more complex problems, identifies variance from
accepted practice, and evaluates impact as necessary.
* Provides guidance and technical knowledge to more junior staff, monitors the
performance of daily tasks.
* May assist with compliance audits as required.
* Facilitate cross-functional meetings with internal and external parties as
required.
* Apply Root Cause Analysis tools to identify root causes and propose effective
corrective and preventive actions.
* Supports management review process through development and generation of
quality system metrics and trending, and escalate issues as required.
* Supports the maintenance and improvement to quality systems processes, as
needed
* Participate in the development of training programs regarding all aspects of
producing quality products, as required.
* Assist compliance audits and provide SME support as required for regulatory
inspections.
* Writes and/or implements changes to controlled documents (e.g., SOPs,
Specifications, Methods, etc.) as needed.
Additional Skills & Qualifications:
Experience with pharmaceutical biologics is required
5+ years of experience with pharmaceutical deviations and CAPAs
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Actalent is an equal opportunity employer.
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Actalent connects passion with purpose. We help visionary companies advance
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that drive scale, innovation, and speed to market. With a network of almost
30,000 engineering and sciences consultants and more than 4,500 clients across
the U.S., Canada, Asia, and Europe, Actalent serves many of the Fortune 500. An
operating company of Allegis Group, the global leader in talent solutions,
Actalent launched as a new specialized engineering and sciences services and
workforce solutions brand in 2021.
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