Job Summary:
The primary purpose of this position is to conduct analytical testing such as cleaning validation, process validation, and stability testing for product development.
Responsibilities:
- Perform routine and non-routine analytical testing to support product development
- Process, analyze, and archive raw data and interpret results accurately
- Second person review raw data
- Maintain inventory of laboratory chemicals and supplies
- Must be able to understand the purpose and objective of validation protocols
- All other duties as may be assigned
Qualifications:
- Education: BS, in Chemistry or a closely related science field from an accredited school
- Experience: 1 - 3 years of basic laboratory experience including hands-on instrument and
software experience, solution preparation, and following SOPs.
- Specialized knowledge: A pharmaceutical, cGMP background with an FDA regulated laboratory.
Familiar with compendial, ICH, and FDA guidelines.
- Other skills: Mathematical calculations, detail-oriented, dexterous sample manipulation.
Analytical instrumentation such as HPLC, Dissolution, UV/Vis, and GC. Motivated self-starter,
productive independent and team worker, with effective writing and laboratory notebook
documentation skills. Computer skills including Microsoft Word and Excel.
- Travel requirements: 0-5
