• Must be a self-starter and self-motivated and able to work and perform essential duties and tasks with little or no supervision. • Write, review, and approve batch records, validation documentation and validation studies and reports on solid dosage forms including tablets and capsules and liquid dosage forms including solutions and suspensions in accordance with FDA regulations/guidelines. • Lead manufacturing process validations, process capability studies and process improvements, provide leadership and training as required to QE personnel a...

PRIMARY TASKS: ? Must be a self-starter and self-motivated and able to work perform primary tasks with minimal supervision. ? Write, review, and approve batch records, validation documentation and validation studies and reports on solid dosage forms including tablets and capsules and liquid dosage forms including solutions and suspensions in accordance with FDA regulations/guidelines. ? Lead manufacturing process validations, process capability studies and process improvements, provide leadership to QE personnel and technicians. ? Review, analyze ...