Quality Control Analyst

Summary

Katalyst CRO is a company focused on providing quality control services in the pharmaceutical sector. They are seeking a Quality Control Analyst to perform various chemical analyses and GMP reviews in compliance with industry standards.

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 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

Skills

• The incumbent must have a BA or BS degree in Chemistry or closely related science
• 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
• Perform job functions in various positions that may require sitting, stooping, balancing, kneeling, crouching, twisting, and/or reaching
• 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
• Minimum of 1-year relevant experience preferred

Qualifications

Must Haves

• The incumbent must have a BA or BS degree in Chemistry or closely related science
• 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
• Perform job functions in various positions that may require sitting, stooping, balancing, kneeling, crouching, twisting, and/or reaching
• 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

Nice to Haves

• Minimum of 1-year relevant experience preferred