Scientist II, Quality Assurance Specialist

4 weeks ago


Danbury, Connecticut, United States MannKind Full time
Job Summary

MannKind is seeking a highly skilled Scientist II, Quality Control to join our team. As a key member of our Quality organization, you will play a critical role in maintaining our quality control systems and ensuring that our products meet the highest standards of quality and regulatory compliance.

Key Responsibilities
  • Conduct routine and non-routine HPLC/GC analysis of raw materials, in process, and finished formulations according to standard operating procedures.
  • Perform chemical analyses of product to ensure stability.
  • Compile data for documentation of test procedures that may include microbiological and/or chemical assays, stability program testing and formulation studies.
  • Calibrate and maintain lab equipment.
  • Participate in the preparation of investigations, summaries and reports.
  • May assist in developing testing methods.
  • Review data obtained for compliance to specifications and report abnormalities.
  • Revise and update standard operating procedures as needed.
  • May perform special projects on analytical and instrument problem solving.
  • Applies knowledge of good manufacturing practices, good laboratory practices and good record keeping practices on a daily basis.
  • Follows written test methods and protocols.
  • Process data, report data and prepare tables and graphs for the completed testing. Identify problems, e.g. out of trend data. Professional interactions are primarily within the QC organization.
  • Responsible for observing all Company, Health, Safety and Environmental guidelines.
Requirements
  • BS Degree in a scientific discipline with 2 to 4 years' experience or MS or MBA 1 to 3 years or related experience or an equivalent combination of training and experience.
  • At least 4 years' experience in a laboratory setting, preferably in pharma.
  • 3-5 years' experience in quality control systems.
  • Good written communication skills.
  • Understanding of GMPs and regulatory guidelines as they relate to the pharmaceutical products preferred.
  • Good interpersonal skills.
  • Access, Excel, Word and Power Point skills.
Working Hours

12:30pm to 9pm, Tuesday to Saturday. Additional stipend earned for working Evening Shift and Saturdays.



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