QC Specialist

Role Summary

Responsible for testing of incoming raw materials, sampling, labeling tracking and shipping of samples. May review GMP documentation and perform data verification. Supports document revision, CAPA and deviation/investigation tasks and/or continuous improvement efforts, and may train others on general job duties.

• Perform routine testing of raw materials and perform sampling of retains. Ship samples to outside testing labs, as needed.
• May review GMP documentation and perform data verification.
• Support document revision, project, CAPA and deviation/investigation related tasks and/or continuous improvement efforts.
• May train others on general job duties.
• Perform other tasks as assigned.

• Ability to accurately and completely understand, follow, interpret and apply Global Regulatory and cGMP requirements.
• Apply scientific principles to analytical testing and the proper use of laboratory equipment.
• Ability to communicate effectively with peers and management regarding task completion, roadblocks, and needs.
• Attention to detail and demonstrated organizational skills.
• Ability to work in a fast-paced team environment, meet deadlines, and prioritize work.

• Bachelor's degree preferred in science. Associate degree with equivalent combination of education and work experience may be considered.
• 0-2+ years of relevant analytical testing or QC experience or equivalent combination of education and experience, preferably in a regulated environment.
• Demonstrated experience with basic laboratory techniques and basic laboratory safety practices.
• Prior experience in analytical testing (e.g., pH, Osmolality, FTIR, HPLC, etc.) is preferred.
• Prior experience in cell and molecular biology techniques (e.g., cell-based assays, flow cytometry, qPCR, aseptic technique) is preferred.