Senior QC Scientist
Company: CoreRx, Inc.
Posted on: March 20, 2020
Performs all essential functions of Analytical Chemist III.
Expected to be the lead scientist for designated projects, to
include direct client communications and attendance at project team
meetings and teleconferences; ability to make autonomous decisions
regarding day to day activities. Demonstrates ability to
independently manage design/development, optimization, validation
and transfer of analytical methods in support of Drug Substances
and Drug products. Provides analytical services to manufacturing,
process development, validation, new material and critical reagent
qualifications. All activities are performed in accordance with
specifications, standard operating procedures, approved test
methods and/or protocols, and regulatory requirements. Analysis of
finished products, in-process materials, raw materials, and
cleaning verification/validation samples according to the assigned
specifications, methods and protocols. Analytical instrumentation
may include, but is not limited to HPLC, GC, TOC Analyzer and
Spectrophotometer. Demonstrates ability to prioritize assignments;
time management and multitasking in a dynamic environment.
Documents all experiments and results thoroughly with detailed
observations. Exercises technical discretion in the design,
execution and interpretation of experiments that contribute to
project strategies and goals. Critically assesses experimental data
and provides interpretation of results, including statistical
analysis. Prepares technical reports, summaries and protocols.
Utilizes independent action and decision making with follow-up
reporting to supervision. Directs and executes experiments of a
scientifically complex nature. Demonstrates ability to interact
effectively within department team, mentoring and training unit
personnel as needed. Appreciates and values different perspectives.
By example, often motivates co-workers and peers to perform their
best work. Evidence of effective communication, both verbally and
written, highly organized, analytical, accurate, and
detail-oriented. Demonstrates ability to work successfully in a
highly collaborative, team oriented, customer focused environment.
Responsible for the preparation of robust processes that lead to
the development of new technologies that support specific client
platforms. Provide support for operations and other process support
teams by providing scientifically sound recommendations, improving
efficiency, meeting of timelines, and the development of successful
processes while operating in compliance with cGMP regulations, and
company SOPs. Performs other related duties as assigned by
management. WORK EXPERIENCE REQUIREMENTS Minimum of 5 years'
experience with identification or separation techniques such as
HPLC, UPLC, GC, and experience with method development and/or
validation EDUCATION REQUIREMENTS Doctorate in scientific field
with 3-years' experience, or MS in scientific field with 5-years'
experience, or BS in scientific field with 10-years' experience in
an analytical environment PHYSICAL DEMANDS Able to stand, sit for
long periods of time. Able to read, write, speak and comprehend the
Keywords: CoreRx, Inc., Clearwater , Senior QC Scientist, Other , Clearwater, Florida
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