BMB and IVD Kit Mfg Associate
Manufacture barcoded magnetic beads (BMB), immuno-chemistry and molecular reagents, in-vitro diagnostic (IVD) and research use only (RUO) products.
· Produces BMBs, reagents, and assists on manufacturing of IVD and RUO products.
· Data entry into ERP system (Syspro).
· Performs warehousing activities.
· Follows all Standard Operating Procedures and Quality System Requirements.
· Meets deadlines.
· Maintains clear and accurate documentation (DMR).
· Maintains adequate supplies and tools.
· Calibrates, monitors and ensures equipment performance.
· Contributes ideas toward process improvement.
· Maintains a high degree of safety awareness and a clean orderly work area.
· Relevant experience in manufacturing of diagnostic products, familiar with general laboratory techniques.
· Bachelor’s degree in life science.
· Working knowledge of IVD manufacturing, cGMP, and QSR.
· Basic knowledge of immune/molecular chemistry principles, theories and practices.
· Demonstrates a sense of urgency, strong work ethics and a “can do” attitude.
· Demonstrates competence in data analysis and report writing.
· Good verbal and written communication skills.
· Good interpersonal skills; ability to work as an effective team member.
· Working knowledge of PC software, preferably Word and Excel.
· Embraces and leverages diversity of culture and thought.
Works in a laboratory environment may require lifting up to 20 lbs., to sit or stand for long periods of time while performing duties. Ability to work safely with hazardous chemicals and infectious agents. Willingness to work overtime and flexible schedule as needed is a plus.