Scientist II, Quality Assurance Specialist
4 weeks ago
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.
- 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.
12:30pm to 9pm, Tuesday to Saturday. Additional stipend earned for working Evening Shift and Saturdays.
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