Quality Specialist I ??? Chemist
Company: System One
Posted on: January 16, 2022
Title: Quality Specialist I - Chemist Location: Wilson, NC Start
date: ASAP Responsibilities:
- 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
- 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.
- Perform all assigned testing in a timely and organized manner
in accordance with cGMP, GLP, DEA and company policies and
- 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
- Communicate openly within the group to provide and gather
information, to optimize the use of resources and to optimize
- Provide training and assistance to other group members.
- Actively participate in investigations, problem solving and
- 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
- Responsible for compliance with Controlled Substance
documentation and accountability procedures and policies while
maintaining high alert to diversion and theft possibilities.
- The incumbent must have a BA or BS degree in Chemistry or
closely related science in addition to 0 - 2 years of laboratory
- 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 Joule, a System One division is a leader in specialized
workforce solutions and integrated services. With more than 6,000
employees and roughly 50 offices throughout the U.S. we provide
scientific, clinical, engineering, energy, IT, legal and
administrative staffing services. For more than 40 years, we have
delivered workforce solutions and integrated services to clients
Keywords: System One, Wilson , Quality Specialist I ??? Chemist, Other , Wilson, North Carolina
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