Scientist III, Quality Assurance Specialist

4 days ago

Danbury, Connecticut, United States MannKind Full time
Job Summary

MannKind is seeking a highly skilled Scientist III, Quality Control to join our development organization. As a key member of our team, you will be responsible for maintaining quality control systems, ensuring performance and products conform to established company and regulatory standards.

Key Responsibilities
  • Analyze chemical, biological, or microbiological products, raw materials, in-process materials, or stability samples in support of our quality program.
  • Interpret and evaluate analyses in terms of accuracy and precision, recommending corrective action where necessary.
  • Perform qualitative tests or quantitative assays on samples using various techniques, from standard analytical equipment to highly modern and automated instrumentation.
  • Conduct routine and non-routine analysis of raw materials, in-process, and finished formulations according to standard operating procedures.
  • Act independently to determine methods and procedures on new assignments, performing experiments in accordance with written procedures and/or under the direction of a supervisor.
  • Manage equipment calibrations/qualifications with minimal supervision.
  • Assist in the development and training of peers and less skilled employees in the execution of analyses and/or the use of specialized equipment.
  • Compile data for documentation of test procedures, including microbiological and chemical assays, stability program testing, and formulation studies.
  • Calibrate and maintain lab equipment, participate in the preparation of investigations, summaries, and reports, and may lead in developing test methods.
  • Review data obtained for compliance to specifications, report abnormalities, and may lead root cause investigations.
  • Write, revise, and update standard operating procedures as needed, and may perform special projects on analytical and instrument problem-solving.
Requirements
  • Bachelor's Degree in Chemistry with 4-6 years of related experience or Master's Degree with 2-4 years of related experience or Ph.D. Degree with 0-2 years of related experience.
  • A working understanding of GMPs and regulatory guidance.
  • Ability to think analytically, with good communication, organizational, and interpersonal skills.
  • Proficient in the use of a word-processing and spreadsheet program, and familiar with Empower.
  • Experience in HPLC analysis and other required analytical techniques.
  • Understanding of GMPs and regulatory guidelines as they relate to pharmaceutical products, preferred.
What We Offer

MannKind offers a competitive salary range of $77,600 - $116,400 per year, a dynamic work environment, and opportunities for professional growth and development.

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