Job Summary:

Performs a variety of chemical analyses and GMP review in accordance with cGMP, GLP, DEA and company policies and procedures.

Position Summary -

• Perform routine testing (dissolution, assay/degradant, content uniformity and ID) of drug products in a cGMP laboratory.
• Complete all assigned testing in a timely and organized manner in accordance with cGMP, GLP, DEA and company policies and procedures.
• Enter data into laboratory information system and accurately document all necessary and relevant information in a clear concise manner as per cGMPs.
• Operate and maintain all analytical instrumentation and equipment as per established procedures; perform basic troubleshooting.
• Communicate openly within the group to provide and gather information, to optimize the use of resources and to optimize efficiency.
• Aid other group members as required.
• Ensure that equipment and working areas are maintained with good safety and housekeeping practices.
• Re-stock chemicals and consumables used in analysis.
• Performs other related assignments and duties as required and assigned.

Education and Experience Requirements:

• The incumbent must have a BA or BS degree in Chemistry or closely related science.
• Minimum of 1-year relevant experience preferred.

Necessary Knowledge, Skills, and Abilities:

• Understanding of analytical technology (HPLC, GC, Dissolution, Automation, or Spectroscopy – UV/Vis, NIR, IR, or AA/AE).
• Relevant experience may include academic and/or industry experience and is measured based on the quality and quantity of the experience as it relates to the requirements of the position.

Physical and Environmental:

• Perform job functions in various positions that may require sitting, stooping, balancing, kneeling, crouching, twisting, and/or reaching. While sitting for an extended period of time on a routine basis, incumbent may use the following equipment: Personal computer, telephone/ other voice communication devices, copier, fax, scanners, or other specialized equipment used in an office setting.
• Lift and maneuver equipment and materials weighing up to 20 pounds.
• Take samples which may require stretching, bending, or twisting to remove product from the equipment and/or drums.
• Use small hand and power tools to perform incidental maintenance.
• Perform cleaning and assembly/disassembly on laboratory equipment which may require pulling, pushing, or twisting to remove equipment shields, parts and panels. Equipment and parts could weigh up to 20 pounds. Also requires operation of industrial hose (water) and physical exertion (repetitive wiping, rubbing and scrubbing) to clean equipment and laboratory surfaces.