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Company: LanceSoft Inc
Location: Wilson
Posted on: November 25, 2022

Job Description:

Title: FTE Quality Specialist I, Chemist
Location: Wilson NC 27893
Duration: Direct Hire/ Permanent Position


  • The Quality Specialist I, Chemist is responsible for supporting the operations and manufacturing process by performing routine and non-routine analytical testing and GMP review in support of the analysis of raw materials, packaging components, ancillary solutions, in-process samples, finished product method development and/or transfers, cleaning/process validations, and stability samples. Will follow standard procedures in accordance with cGMP, GLP, DEA and company policies and procedures.

    Primary 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.

      Education and Experience 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.

          Additional Information

          • 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: LanceSoft Inc, Wilson , Chemist, Other , Wilson, North Carolina

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