Job Description
Job Description
Working Hours: 36 Hours per week (Fri-Sat-Sun)
Weekend Shift Timings: 6:00 AM – 6:30 PM
Training Shift: Please note, the worker will start on 1st shift (7:00 AM – 5:30 PM) until September 2024 for the training period, after which they will begin the weekend shift.
Job Summary
- Performs a variety of chemical analyses and GMP review in accordance with cGMP, GLP, DEA, and company policies and procedures.
Primary Responsibilities
- 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 the 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.
- Perform 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 a 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 on a routine basis, the 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.