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Quality Specialist - Chemist

Company: Katalyst Healthcares & Life Sciences
Location: Wilson
Posted on: May 16, 2023

Job Description:

Job Description


  • Perform all assigned testing in a timely and organized manner in accordance with cGMP, GLP, DEA and company policies and procedures.
  • Document all necessary and relevant information in an accurate and 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.
  • ctively 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.
  • ssist in writing and performing method validations and method transfers and assist in process validations.
  • Perform equipment validations IQs, OQs, PQs, and MQs, if necessary, provide assistance and technical support to other groups with chemical testing needs and perform troubleshooting of analytical methods and instrumentation.
  • Perform other related assignments and duties as required and assigned. Requirements:
    • The incumbent must have a BA or BS degree in Chemistry or closely related science in addition to 0 to 2 years of laboratory experience.
    • 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.
    • Supervisory Responsibilities (if Applicable)
    • There are no positions reporting to this position.

Keywords: Katalyst Healthcares & Life Sciences, Wilson , Quality Specialist - Chemist, Other , Wilson, North Carolina

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