Quality Chemist
Company: Howard Systems International
Location: Wilson
Posted on: January 25, 2023
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Job Description:
Howard Systems seeks a Quality Chemist for a contract role in
Wilson, NC.
Job Summary
Performs a variety of chemical analysis and GMP review of raw
materials, packaging components, ancillary solutions, in-process
samples, finished product and stability samples in accordance with
cGMP, GLP, DEA and company policies and procedures. -Assists in
writing and performing method validations and method transfers.
-Assists in process validations. Conducts equipment validations
IQs, OQs, PQs, and MQs, if necessary. -Provides assistance and
technical support to other groups with chemical testing needs and
performs troubleshooting of analytical methods and
instrumentation.
Primary Responsibilities
Perform all assigned testing in a timely and organized manner in
accordance with cGMP, GLP, DEA and company policies and
procedures.
Accurately document all necessary and relevant information in a
clear concise manner as per cGMPs.
Operate and maintain all analytical instrumentation and equipment
as per established procedures.
Write, revise, develop and evaluate operational and maintenance
procedures.
Communicate openly within the group to provide and gather
information, to optimize the use of resources and to optimize
efficiency.
Provide training and assistance to other group members.
Actively participate in investigations, problem solving and
troubleshooting.
Ensure that equipment and working areas are maintained with good
safety and housekeeping practices.
Re-stock chemicals and consumables used in analysis.
Prepare and present data summaries (written and oral) as
necessary.
Responsible for compliance with Controlled Substance documentation
and accountability procedures and policies while maintaining high
alert to diversion and theft possibilities.
Performs other related assignments and duties as required and
assigned.
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Education and Experience Requirements
The incumbent must have a BA or BS degree in Chemistry or closely
related science in addition to 0 - 2 years of laboratory
experience. -
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Necessary Knowledge, Skills, and Abilities
Must demonstrate comprehension of at least one analytical
technology (HPLC, GC, Dissolution, Automation, or Spectroscopy -
UV/Vis, NIR, IR, or AA/AE); and should have a familiarity with
cGMPs and FDA requirements. -Must pass an internal GMP Training
course and be computer literate
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Supervisory Responsibilities (if Applicable)
There are no positions reporting to this position.
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Additional Information
N/A
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Summary of Work:
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Local candidates only and Science related BS degree with 0-2 years
only.
Hours: 7am - 5:30 pm (some flexibility but shift is 10.5 hrs w/ - -
hr unpaid meal period)
Job Title: Quality Specialist - Chemist
Duration: 6 - 12 months
Location: Wilson, NC (Onsite)
Keywords: Howard Systems International, Wilson , Quality Chemist, Other , Wilson, North Carolina
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