Associate Scientist, Quality Control (2025-026-397)

Essential Duties and Responsibilities

• 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.

Minium Qualification Requirements

• A minimum of a Bachelors degree in a scientific discipline with a minimum of 8 years cGMP analytical experience is required.
• Or advanced degree (MS with a minimum of 5-6 years or PhD with a minimum of 0-2 years) in related area with experience.
• Must have a demonstrated working knowledge of scientific principles.
• Practical experience in analytical chemistry and general laboratory wet chemistry techniques required.
• Experience in GC is strongly preferred with NMR experience, being a plus.
• Experience in data analysis, troubleshooting and problem-solving skills is a must.
• Knowledge of FDA regulations and cGMPs for drugs and/or device are 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).