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Sr. Quality Specialist - Chemist

Company: Katalyst Healthcares & Life Sciences
Location: Wilson
Posted on: November 26, 2022

Job Description:

Perform a variety of chemical analyses and GMP review of raw materials, packaging components, ancillary solutions, in-process samples, finished product samples, and stability samples in accordance with cGMP, GLP, DEA, and company policies and procedures. Author and review protocols for method development, method validation, method transfer, and/or process validation. Execute protocol testing, data review, report writing, and report reviewing. Conduct equipment validations IQs, OQs, PQs, and MQs, if necessary. Provide assistance and technical support to other groups with chemical testing needs and performs troubleshooting of analytical methods and instrumentation. May be responsible for technical supervision of Quality colleagues and serve as back-up to management to ensure smooth and efficient operation of the lab.

Primary Responsibilities

  • Serve as an analytical project lead for all assigned products.
  • Project leads ensure all required testing is completed to support the overall project timeline.
  • 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.
  • Exercises good judgment in interpreting, understanding context, and reporting data.
  • Proactively identifies potential problems and recommend solutions.
  • Prepares, writes, and distributes reports as appropriate.
  • Participates in preparation and revision of job-related controlled documents.
  • Performs analytical testing of samples under limited direction.
  • Supports the creation, revision and development of test methods, operational and maintenance procedures, and other job-related controlled documents.
  • Evaluates accuracy, completeness, and adequacy of reports.
  • Independently prioritizes workload.
  • Requires minimal guidance and supervision when conducting routine and non-routine activities in primary discipline.
  • May interact with other departments/teams within the Company and with external regulatory agencies and business partners.
  • Performs other related assignments and duties as required and assigned.

    Education and Experience

    • The incumbent must have a BA or BS degree in Chemistry or closely related science with six years minimum laboratory experience in pharmaceutical or related industries; or a graduate degree (MS Preferred) with 4-7 years' experience.
    • Relevant experience may include academic and/or industry experience and is measured based on the quality and quantity of the experience as it relates to the requirements of the position.

      Necessary Knowledge, Skills, and Abilities

      • Must demonstrate sound comprehension of multiple analytical technologies (HPLC, GC, Dissolution, Automation, or Spectroscopy - UV/Vis, Raman or IR); and must have a comprehensive knowledge of cGMPs and FDA requirements as well as familiarity with USP and EP monographs.
      • Supervisory Responsibilities (if Applicable) All Sr. Quality Specialist I (Method Development Chemist) report to the Manager/Senior Manager.
      • The Sr. Quality Specialist I may supervise junior staff including temporary staff and interns. Additional Information Problem Solving:
      • Effectively identifies, describes and communicates problem and impact in a timely manner.
      • Routinely participates in problem resolution.
      • Identifies, tracks and resolves issues to closure.
      • Proactively identifies potential problems and recommends possible solutions.

        Data Analysis/Reporting:

        • Evaluates accuracy, completeness and adequacy of reports.
        • Authors, revises and annotates job-related controlled documents.

          Leadership Competencies:

          • May train Quality colleagues in processes and procedures.
          • May be responsible for technical supervision of Quality colleagues.

            This may include:

            • Assigning work
            • Day-to-day supervision
            • Input to performance evaluation
            • Participating in hiring process
            • Organizes and coordinates activities for assigned projects anticipating future needs

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

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