Provides internal support functions to assigned QC Laboratory Services initiatives; i.e. LIMS, Raw Materials, Technical Writing, Stability Program, Training initiatives. Prepares/revises documentation such as forms, SOPs, Protocols, and Quality Systems reports, etc. Viewed as a resource in the area and uses knowledge and creativity to resolve problems. Designs, conducts, and implements training materials.
Must function well as a team player as well as have a capacity for independent functioning and decision making. Ability to take initiative and carry out projects appropriately with minimal direction; strong communication, and customer service skills; ability to prioritize and troubleshoot; ability to exercise logical resourceful thinking and demonstrate flexibility while handling multiple priorities; ability to develop and foster teamwork between Lab and other departments. Excellent written and verbal communication skills. Strong customer focus. Requires excellent computer skills and familiarity with SOP technical writing procedures.
Requires a Bachelor’s degree in Biology, Chemistry, Medical Technology, or related scientific field. Some experience in a regulated laboratory setting, and previous work experience in a regulated environment (FDA, EPA, etc.) is preferred. The ideal candidate will be familiar with GLP and GMP guidelines.