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FTE Quality Specialist I, Chemist

Company: Katalyst Healthcares & Life Sciences
Location: Wilson
Posted on: November 24, 2022

Job Description:

Responsibilities:


  • 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.
  • 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.
  • Assist 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 . The incumbent must have a BA or BS degree in Chemistry or closely related science. Prior GxP laboratory experience of six months - two years is highly preferred.
    • 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 have a familiarity with computerized laboratory environment.
    • Supervisory Responsibilities (if Applicable)
    • There are no positions reporting to this position.
    • Minimum required education, experience, knowledge, skills and abilities are included in the posting. The position will be filled at the level commensurate with the successful candidate's education, experience, knowledge, skills, and abilities.
    • The job description is not an exhaustive list of all functions that the employee may be required to perform, and the employee may be required to perform additional functions. Additionally, the company may revise the job description at any time.

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

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