Biomanufacturing Quality Assurance Floor Support
Company: American CyberSystems, Inc.
Location: Ayer
Posted on: May 8, 2022
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Job Description:
Title:- Biomanufacturing Quality Assurance Floor Support
Location: Devens, MA Duration: 07 MonthsDescription:- Provide
Quality assistance and oversight to operations, for in-process
intermediates and manufactured products, and other GMP processes as
required. Performs review and approval of documentation associated
with in-process materials, and manufactured product. Assists in the
identification, generation and quality review of investigation
records that may result during day-to-day operations. Assure the
quality of manufactured products complies with all applicable
regulations and guidelines.Performs routine manufacturing batch
production record review in support of product release in
accordance with specifications and SOPs.Assist Operations by
providing quality oversight and guidance for atypical events,
assessing complex biologics manufacturing issues for forward
processing.Perform walkthroughs of GMP areas documenting
observations and areas of concern to support audit readiness of the
manufacturing facility and support areas.Supports return to service
walkthroughs and Manufacturing audit readiness walkthroughs per
procedures as needed.Assures all electronic and paper
documentation, which requires QA review is in compliance with
corporate and site procedures, cGMP regulations, and other industry
guidelines.Reviews, approves and provides guidance for quality
master dataAuthors and revises Quality specific SOPs and may
provide Quality review and approval of manufacturing related
SOPs.Monitors and trends batch record errors, batch record review
cycle time to support disposition, and walkthrough observations to
provide Quality Assurance management with quality indicator
data.May support the Quality approval of Master Batch
Records.Supports the Quality review and closure manufacturing
deviations.Other duties as assigned.Knowledge of science generally
attained through studies resulting in a B.S., in science,
engineering, biochemistry or related discipline, or its equivalent
is preferred.A minimum of 6-10 years of relevant experience in a
regulated environment with 2-4 years focused on product quality
preferredDemonstrated ability to independently assess complex
manufacturing and automation issuesKnowledge of biotech cell
culture, protein purification, bulk and finished product
manufacturing is required\Knowledge of US and EU cGMP regulations
and guidance.Knowledge of manufacturing batch record execution and
review, maintenance execution approval, inventory management, and
deviation management and approval is desirable.
Keywords: American CyberSystems, Inc., Nashua , Biomanufacturing Quality Assurance Floor Support, Other , Ayer, New Hampshire
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