Job Description
Essential Duties and Responsibilities - This is a 2nd Shift role. Regular work hours are 4:00pm - 1:00am, Sunday through Thursday.
- Works on complex problems in which analysis of data requires evaluation of various factors.
- Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
- Responsible for conducting routine and non-routine analysis of In-Process/Reaction intermediate and Finished materials according to standard operating procedures.
- Compiles data for documentation of test procedures and prepares reports.
- Calibrates and maintains lab equipment.
- May develop testing methods.
- Reviews data obtained for compliance to specifications and reports abnormalities.
- Revises and updates standard operating procedures as needed.
- May perform special projects on analytical and instrument problem solving.
- Applies knowledge of good manufacturing practices and good laboratory practices daily basis.
- Works on complex problems where analysis of situations or data requires an evaluation of intangible variables.
- Exercises independent judgment in developing methods, techniques and evaluation criteria for obtaining results.
- Acts independently to determine methods and procedures on new assignments.
- Provides data analysis, troubleshooting and problem solving.
- Provides training to junior analysts. Supports QC release and stability testing.
- Performs various analyses, such as NMR, HPLC, UV-Vis spectroscopy, GC, particle size determination and moisture analysis.
- Maintains accurate and well-organized laboratory records and worksheets.
- Assists with other projects as assigned.
- Recognize OOT/OOS results and appropriately conduct investigation.
- May perform rotational on-call duties for monitoring of storage chambers, as necessary
Minimum Qualification Requirements - A minimum of a Bachelors degree in a scientific discipline with a minimum of 5 years cGMP analytical experience is required.
- Must have a demonstrated working knowledge of scientific principles.
- Practical experience in analytical chemistry and general laboratory wet chemistry techniques required.
- Experience in HPLC a must, with GC/ NMR experience, being a plus.
- Experience in data analysis, troubleshooting and problem-solving skills is a must.
- Knowledge of FDA regulations and cGMP experience required.
- Experience in data analysis, troubleshooting and problem-solving skills is required.
- Good oral and written communication skills are required.
- Good computer and documentation skills are required.
- Experience with Empower software is required.
- Must be well organized and willing to work as part of a team.
- Must be able to work independently and flexible.
Physical Requirements - Must be able to pass pre-employment drug screening and background check for employment consideration.
- Employees must be able to lift or handle objects greater than 25 pounds to perform certain duties essential to the job function.
- Employees may be required to perform tasks essential to the job function in areas that require the use of hearing protection devices.
- Performance of tasks essential to the job function may require the employee to work directly with, handle, or otherwise come into contact with chemicals or pharmaceutical agents.
- Employees must be able to maneuver themselves under 30 inch clearances.
- Employees must be able to able to accurately detect color and have 20/20 vision (with/without corrective lenses).
Job Tags
Flexible hours, Night shift, Afternoon shift,